21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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