21 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HAW·April 19, 2017
Sani-Tip®
FDA UDI
Dentsply Professional·D0031222111·Sani-TIP Disposable Air Water Syringe Tips, 250...
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948007411·DURAVENT UNI XL 1 IC + 1 ICU, SIZE 11
VEO Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996188036·VEO,BULLETED TRIAL,12 DEG,22X11
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113508·PS-C Insert, Size 2 x 11mm
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505994·Gutta Percha Points is used to root canal filin...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973325·
HLS UNI EVOLUTION PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
CRUISER 18 GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 13, 2011
S8 ELITE- AMERICAS
FDA Adverse Event
Malfunction
·Product code BZD·August 15, 2008
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013
FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HSB·March 3, 2025
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013
REPLICA LG STAT LNG LT 16.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 9, 2013
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