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

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Montage Flowable Settable, Resorbable Bone Paste

FDA 510(k)
FDA Class 2 ·Orthopedic

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022724·Dornier 600 µm Single-Use SMA Diode Laser Fiber...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111163197·SKLARLITE SKLRCT IRIS CVD 4.5"

ELMED

FDA UDI
ELMED INCORPORATED·00842180161078·Prism Cervical Curette, 10", Angled 2, Dark Blue.

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)
FDA Class 2 ·Immunology

CIV-Clear cover

FDA 510(k)
FDA Class 2 ·Radiology

DRILL, AO, STERILE 4, 2X340 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

OPTILITE® FREELITE® KAPPA FREE KIT

FDA Adverse Event
Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

OPTILITE® FREELITE® KAPPA FREE KIT

FDA Adverse Event
Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

TENDRIL STS

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

ARTICULATED ECCENTER EXTRACTOR F/GUIDE B

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWB·July 17, 2013

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014