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

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SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code HRS·August 15, 2017

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601598·SPACER 2111540 OLIF25 20MM 6 DEG 16X40

RESTORIS

FDA UDI
MAKO SURGICAL CORP.·00848486017286·MCK PATELLA SIZING GUIDE ASSY (HANDLE)

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300683·

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm

OptumSI Implant System

FDA UDI
SI Solutions, LLC·00850057247190·Sacroiliac Joint Fusion Implant, 11.5mm x 40mm

Sklar

FDA UDI
SKLAR CORPORATION·10649111157929·MURPHY PLASTER KNIFE WOOD HDL

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213033252·Coupling Treatment Tube for Metal Needles (23)

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded

Experience

FDA UDI
Gc Orthodontics America Inc.·E53511154000201·EXC MBT 018/U4&5 UNIV -7T 0A

Experience

FDA UDI
Gc Orthodontics America Inc.·D78811154000201·EXC MBT 018/U4&5 UNIV -7T 0A

VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07

FDA 510(k)
FDA Class 2 ·Cardiovascular

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

FDA 510(k)
FDA Class 2 ·Dental

LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code PAH·May 14, 2013

UNKNOWN DEPUY ASR SZ. 54 CUP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

STARCLOSE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 13, 2008

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026