14 results · 27ms · Sources: EU EUDAMED, US FDA

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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