26 results
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21ms
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Sources: EU EUDAMED, US FDA
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
FDA UDI
Paonan Biotech Co.,Ltd.·04719878786805·Rod Template 120 mm
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996190497·THUNDERBOLT,X-TAB SCREW,6.0X60X120
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996189897·THUNDERBOLT,X-TAB SCREW,5.0X60X120
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312025·REAMER Ø20 mm / HUDSON
Canaveral®
FDA UDI
FLOSPINE LLC·B183120601200·6.0mm Curved Rod, Ti Alloy 120mm
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
FDA 510(k)
FDA Class 2
·Orthopedic
PRO-TORQ
FDA 510(k)
FDA Class 1
·Dental
Widex
FDA UDI
Widex A/S·05706069796704·Widex EVOKE E-CIC (Light beige ) 220, Right, RC...
Widex
FDA UDI
Widex A/S·05706069796711·Widex EVOKE E-CIC (Clay brown ) 220, Right, RC ...
Widex
FDA UDI
Widex A/S·05706069796728·Widex EVOKE E-CIC (Dark brown ) 220, Right, RC ...
SUPERA PERIPHERAL STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIP·September 19, 2019
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
FDA Adverse Event
Injury
·COVIDIEN·Product code FGE·February 16, 2026
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 5, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 10, 2008
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 15, 2011
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 25, 2013
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 7, 2022
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·December 6, 2017
PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FGE·November 27, 2025