26 results · 21ms · Sources: EU EUDAMED, US FDA

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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