20 results · 44ms · Sources: EU EUDAMED, US FDA

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ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NA

FDA UDI
Smith & Nephew, Inc.·03596010584731·KEY PERIOSTEAL ELEVATOR 12.7 BL ...

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657084277·LAP FORCEP CABLE

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657004657·Monopolar Cord

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08806390880664·

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089402816·

MODIFICATION TO THE BOLD SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

FLEXI-LITE

FDA 510(k)
FDA Class 2 ·Anesthesiology

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013

CONTOUR USB

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

CONTOUR NEXT

FDA Adverse Event
Injury ·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012

ZIMMER PATIENT SPECIFIC INSTRUMENT

FDA Adverse Event
Injury ·MATERIALISE N.V.·Product code MBH·May 8, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 23, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 1, 2015

BD DISCARDIT¿ II 10 ML SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 1, 2022

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025