14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TE Air Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318287·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...
ELMED
FDA UDI
ELMED INCORPORATED·00842180164659·Medium 5.0mm Nathanson Retractor, Robotic Shaft...
HUMERIS 135
FDA UDI
FX SOLUTIONS·03701037318621·HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY PE/TA...
ELMED
FDA UDI
ELMED INCORPORATED·00842180165793·Medium 5.0mm Nathanson Retractor, Robotic Shaft...
MINICONE Implant
FDA 510(k)
FDA Class 2
·Dental
CALIBRA CEMENT
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
SAMSUNG GALAXY WATCH 5 PRO (Z9NL)
FDA Adverse Event
Malfunction
·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026
PYXIS ANESTHESIA SYSTEM (PAS)
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BRY·August 8, 2011
DXTEND STAND PE CUP D38 +9MM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWS·November 10, 2014
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·July 17, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019