13 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

COLLAGEN TENDON SHEET-D

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

ArgenZ HT+ 98x18 D2

FDA UDI
ARGEN CORPORATION, THE·D818122048·Dental porcelain/ceramic restoration kit

Logical PX-Series

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000363·

INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ATRAUMATIC VASCULAR CLAMPS

FDA 510(k)
FDA Class 2 ·Cardiovascular

COTTON-HUIBREGTSE BILIARY STENT

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FGE·July 14, 2022

PROMUS ELEMENT ? LONG

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2013

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 14, 2008

SAFESHEATH II 9F

FDA Adverse Event
Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014