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

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VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

LuxaPost

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107830·Glass fiber-reinforced pre-silanized composite ...

JOBST Men's Dress

FDA UDI
BSN MEDICAL, INC.·00035664107833·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE EXT...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818318·AXS Instrument Holder- Hex QC Holder- Stainless

IRIS SCISSORS CVD.S/S 110MM

FDA Adverse Event
Injury ·AESCULAP AG·Product code LRW·August 19, 2022

COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE

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

2.0/2.4 CANNULATED SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESPIRONICS

FDA Adverse Event
Malfunction ·Product code MNT·April 8, 2021

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·August 15, 2019

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024