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