21 results · 25ms · Sources: EU EUDAMED, US FDA

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HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

ZMR®

FDA UDI
Zimmer, Inc.·00889024157224·

ZMR®

FDA UDI
Zimmer, Inc.·00889024157231·

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

PACESETTER MODEL 350

FDA 510(k)
FDA Class 2 ·Cardiovascular

CATGUT CHROMIC 2/0 (3.5) 100M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 27, 2018

CATGUT CHROMIC 3 (7) 50M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 20, 2018

PDS LL PLUS ANTIBACTERIAL SUTURE

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code NEW·March 7, 2013

UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 15, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

CATGUT PLAIN 3/0 (3) 100M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·May 28, 2020

CATGUT PLAIN 1 (5) 75M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·July 20, 2020

CATGUT PLAIN 1 (5) 75M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 10, 2021

CATGUT CHROMIC 2 (6) 50M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 25, 2021

MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·February 17, 2020

CATGUT PLAIN 6 (10) 25M D2

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·July 16, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·October 29, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017