13 results · 20ms · Sources: EU EUDAMED, US FDA

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INFILL GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

Bone cutters

FDA UDI
DFS - DIAMON GmbH·04057176148056·Bone Cutter type 163 HP

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213026353·microSelectron Transfer Tube for 6F Flexibles (22)

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

LUCENT OR LUCENT MAGNUM

FDA 510(k)
FDA Class 2 ·Orthopedic

METAFLEXCOIL

FDA 510(k)
FDA Class 2 ·Radiology

ASKU

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWS·February 15, 2011

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 6, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011

STERLING MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·August 13, 2008

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021