14 results
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27ms
·
Sources: EU EUDAMED, US FDA
SRH-678 VACCUUM TUBING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOBILIUM
FDA UDI
CMP INDUSTRIES LLC·M4829202100·CHARACTER PLUS ALLOY 1KG
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113072·PS Insert, Size 2 x 10mm
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110942·STERILIZING CASE PLASTIC SMALL
Arthrex®
FDA UDI
ARTHREX, INC.·00888867058354·UNIVERS SCREWDRIVER
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Disposable Endoscopy Adapter Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code KWS·October 4, 2021
VERSA-DIAL 42X18X46 HUM HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 18, 2017
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·December 10, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 8, 2014
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 17, 2012
EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019