39 results · 23ms · Sources: EU EUDAMED, US FDA

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EARPROBE

FDA 510(k)
FDA Class 2 ·Neurology

Criterion OxiCheck

FDA UDI
Respironics Novametrix, LLC·00884838083189·

Eclipse Vent Diffuser Kit

FDA UDI
BLEEP, LLC·00850003157177·

NITANIUM® SUPER ELASTIC ARCHWIRES

FDA UDI
Ortho Organizers, Inc.·00190707059743·.016 X .016 LOWER NITANIUM® SUPER ELASTIC PRO F...

Monoblock Tibial Trial PS Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042646·

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494462153·Bone Chisel Awl Plastic Handle D 3.0mm, WL 310mm

RANDOX PREALBUMIN

FDA 510(k)
FDA Class 1 ·Immunology

MODIFICATION TO TISSUELINK BIPOLAR FORCEPS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IOR·May 8, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 17, 2011

TRANSSEPTAL NEEDLE, BRK SERIES

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DRC·October 20, 2021

Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

FDA Enforcement
Class II ·Terminated·Zimmer, Inc.·January 8, 2014

NOVOSYN QUICK UNDY 2/0(3)70CM DSMP24MDDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·April 23, 2021

NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2021

NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 29, 2021

NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021