327 results · 22ms · Sources: EU EUDAMED, US FDA

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PRECICONTROL CLINCHEM MULTI 1 AND 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193108117·HA PEEK EVOS Straight, ,16mmx8mmx 30mm , FLAT ...

RHEAD

FDA UDI
Stryker GmbH·00886385024073·Stem Implant 6mm Collar,Size 3

ALL SILICONE FOLEY BALLOON CATHETER

FDA UDI
Sewoon Medical Co., Ltd.·08806369402521·2way/Translucent 30cc 16fr

Mariner Deformity

FDA UDI
Seaspine Orthopedics Corporation·10889981298012·Closed Polyaxial Screwdriver, Cannulated, Navig...

INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHILIPS INTEGRIS ALLURA

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
STRYKER CORPORATION·07613154410422·1.6mm Lindemann Drill Bit

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981308353·4-Blade Lateral Paddle Shaver, 16mm

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837026004·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...

EchoLUTION Viral RNA/DNA Kit (16 x 96)

FDA UDI
BioEcho Life Sciences GmbH·04260759850226·

NORIAN REINFORCED FAST SET PUTTY/3CC

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 22, 2017

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·November 16, 2017

EVOLUT FX VALVE

FDA Adverse Event
Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 15, 2025

rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA Enforcement
Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

TCM CombiM Modules 903-111

FDA Recall
Terminated ·Radiometer America Inc·Product code LKD·November 18, 2015