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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 Cerebral Assessment Systems, Inc. Charles J. Duffy, MD, PhD, Founder and CEO 2850 Clover Street Pittsford, NY 14534 Re: DEN130033 Cognivue

Actived: Just Now

URL: https://www.accessdata.fda.gov/cdrh_docs/pdf13/DEN130033.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES …

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 InFront Medical, LLC Mr. John D. Kuczynski President 1033 U.S. Highway 46 East, Suite A202 Clifton, New Jersey 07013 Re: K141443

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Boston-Biomedical Associates Lauren Baker President and CEO 100 Crowley Drive, Suite 216 Marlborough, MA 01752 Re: K170757 Trade/Device Name: Aegis Transit System

Category:  Food,  Medical Go Health

Health Beacons, Inc. ℅ Felicia Hosey Senior Principal

Health Beacons RFID Localization . Product Features Proposed Device Health Beacons, Inc. RFID Localization System (RFLS) Predicate Device . System (K190932) Indications for Use . The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as

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Carestream Health, Inc. December 2, 2020 Gina …

Carestream Health, Inc 150 Verona Street Rochester, New York 14608 Contact: Gina Maiolo Regulatory Affairs Manager 585.627.6543 Carestream Health, Inc. is submitting this Special 510(k) premarket notification for modifications to the DRX Plus 3543 Flat Panel Detector. Caresteam believes the modified DRX Plus 3543C Flat Panel

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Resonance Health Analysis Services Pty Ltd. December 7

Resonance Health Analysis Services Pty Ltd. December 7, 2020 ℅ Ms. Alison Laws CEO 141 Burswood Road Burswood, Western Australia 6100 AUSTRALIA Re: K201039 Trade/Device Name: HepaFat-AI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH

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Michael Billig Co-Founder and Chief Executive Officer

Avenda Health, Inc. ℅ Michael Billig Co-Founder and Chief Executive Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110 Re: K201687 Trade/Device Name: Avenda Health Treatment System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In

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Cleerly, Inc. October 2, 2020 Partner Hogan Lovells …

Department of Health and Human Services Food and Drug Administration . Office of Chief Information Officer . Paperwork Reduction Act (PRA) Staff . [email protected] “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.” 046 K202280

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DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH & HUMAN SERVICES Fublic Health Service WN-qa “-\ Food and Drug Administration Rockville MD 20857 NDA 18-654/S-018& S-029 OEc 3 I 1996 ~offmann-La Roche Inc. 340 Kingsland St.

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Peginterferon alfa-2b

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 January 19, 2001 Our STN: BL 103949 (replaces Ref. No. 99-1488) Nicholas J. Pelliccione, Ph.D. Schering Corporation 2000 Galloping Hill Road Kenilworth, NJ 07033 Dear Dr. Pelliccione:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 Covidien, LLC Kristine Canavan Vice President, Regulatory and Quality 951 Aviation Parkway, Suite 900 Morrisville, NC 27560 Re: P140018 VenaSeal Closure System

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Radiation-Emitting Product Codes

No standard applicable. General Radiological Health requirements apply. [1000-1005]; NRZ: ablation system, high intensity focused ultrasound (hifu), mr-guided Acoustic IYE: accelerator, linear, medical Ionizing No standard applicable. General Radiological Health requirements apply.

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Interactive Nutrition Facts Label

The human body needs the right "mix" of nutrients for good health. Consuming the recommended daily amounts of vitamins and minerals in addition to carbohydrate, protein, fat, and dietary fiber helps support many important body processes. See the Vitamins and Minerals Chart for functions that each vitamin and mineral perform in the body.

Category:  Vitamin Go Health

K200748.Decision Summary, 8.23

The Visby Medical Sexual Health Click Test is a single-use (disposable), fully-integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use in point-of-care or clinical laboratory settings for the rapid detection and differentiation of DNA from . Chlamydia trachomatis,

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Class 2 Device Recall Cardinal Health" Angiographic Drapes

Cardinal Health 200, LLC 3651 Birchwood Dr Waukegan IL 60085-8337: Manufacturer Reason for Recall: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. FDA Determined

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Serology Test Evaluation Report for “Megna Rapid COVID-19

Health Inc. Megna Rapid COVID-19 IgM/IgG Combo Test Kit is intended to detect. Positive and neg-ative predictive values were calculated for combined sensitivity and specificity assuming a prevalence of 5%. Cross-reactivity with HIV+ was evaluated, and results are presented separately. If cross-reactivity

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Class 2 Device Recall Health Harmony Mobile

Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a

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Cassie Lee Manager Suite 306, Kecheng Mansion, No.121

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K193621 Device Name Digital Thermometer (Model: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) Indications for Use (Describe)

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Summary of Safety and Effectivness (SSED)Template

qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings.

Category:  Cancer Go Health

Class 2 Device Recall FREESTYLE LIBRE 14 DAY GLUCOSE

On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2.

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …

Health Check, with two additional samples positive for Syphilis Health Check. Two samples from Lyme disease and HSV showed a positive result with Syphilis Health Check but could not be confirmed. One sample each from CMV positive and heterophile positive patients were Syphilis Health Check positive, but non-reactive by reference methods.

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Class 2 Device Recall GUM PerioShield

Class 2 Device Recall GUM PerioShield. SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

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The 23andMe Personal Genome Service (PGS) Genetic Health

Health Risk Report for BRCA1/BRCA2 (Selected Variants). The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast

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[email protected]: FDA-Approved Drugs

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/28/2021: SUPPL-10: Efficacy-Labeling Change With Clinical Data

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …

The Helix Genetic Health Risk App for late-onset Alzheimer’s disease is intended to provide the late-onset Alzheimer’s disease risk report. The report is based on a qualitative genetic test for detecting single nucleotide polymorphisms (SNP), rs429358 and rs7412, and for reporting e2, e3

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Class 2 Device Recall Covidien

Cardinal Health 200, LLC 15 Hampshire St Bldg 5 Mansfield MA 02048-1113: Manufacturer Reason for Recall: Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens FDA Determined Cause 2: Equipment

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MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM

MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM. In this use of jada, care was escalated for the original diagnosis of postpartum hemorrhage, consistent with the device labeling. The user facility did not allege that the device caused or contributed to patient injury or escalation of care.

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Serology Test Evaluation Report for “MEDsan biological

The MEDsan biological health solutions, MEDsan COVID-19 IgM/IgG Rapid Test from MEDsan GmbH was tested on 2020-06-01 at the Frederick National Laboratory for Cancer Research (FNLCR), a Fed-erally Funded Research and Development Center (FFRDC) sponsored by the National Cancer In-stitute (NCI). The lot number for the tests was not provided.

Category:  Cancer Go Health

MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM

MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM. We are unable to determine if the jada device malfunctioned or if the patient experienced any adverse effects from the reported expulsion of her jada device as the requested additional information has not been provided as of 09/16/2021.

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Cardo Medfical Femoral Cement ResrictorPremarket

DEPARTMENT OF HEALTH &o HUMAN SERVICES Public Health Service Food and Drug Administration 10903 Newv l-ampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Cardo Medical, Inc.JU,-821 % Ms. Dina L. Weissman, J.D. JL 821 Director, Quality Assurance Regulatory Affairs and Government Compliance

Category:  Food,  Medical Go Health

Class 2 Device Recall Genius 2 and Genius 3 Tympanic

Cardinal Health 200, LLC 15 Hampshire St Bldg 5 Mansfield MA 02048-1113: Manufacturer Reason for Recall: The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers).

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HIGHLIGHTS OF PRESCRIBING INFORMATION weeks, 1200 …

weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. (2.2) weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to ⎯ Injection: 840 mg/14 mL (60 mg/mL) and 1200 mg/20 mL (60

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JKH Health Co., Ltd. %LOO Quanqin Dai, Ph.D. 1142 S

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 JKH Health Co., Ltd. %LOO Quanqin Dai, Ph.D. Application Correspondent 1142 S. Diamond Bar Blvd, #861 Diamond Bar, CA 91765 Re: K153520

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Class 3 Device Recall Cardinal Health Hydroxybutyrate

Class 3 Device Recall Cardinal Health Hydroxybutyrate LiquiColor. Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092; Deterioration in the stability of the

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Class 2 Device Recall Precice System

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.

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Harbour Health LLC ℅ Dave Yungvirt CEO 25 Independence

The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are

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DE NOVO CLASSIFICATION R F CAPTION G

Caption Health, Inc. 2000 Sierra Point Pkwy, 8th Floor Brisbane, CA 94005 . I. NDICATIONS . F. OR . U. SE . The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems.

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Class 1 Device Recall Covidien

Cardinal Health issued Urgent Medical Device Correction letter and Acknowledgement Form on June 16, 2021 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1) REVIEW the IFU for the Safety Scalpel N11 (vendor part number 73-1811).

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