19 results · 24ms · Sources: EU EUDAMED, US FDA

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BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

FDA 510(k)
FDA Class 2 ·Microbiology

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857235557·Universal Connector Driver, AO

INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2022

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

SECURE 3 MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 29, 2011

BD MICROLANCE¿ NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 7, 2018

2ML BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 14, 2017

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021