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

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ENSEAL G2 TISSUS SEALERS

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

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

OmniLab Direct

FDA UDI
Respironics, Inc.·00606959038752·OmniLab Direct

OmniLab Direct

FDA UDI
Respironics, Inc.·00606959044302·OmniLab Direct Software

Fuji

FDA UDI
LANCER ORTHODONTICS, INC.·00817573024438·GC FUJI CAPSULE APPLIER II

Reprocessed 3mm Straight Shaver Blade

FDA UDI
SURETEK MEDICAL·B39062901120331·

PELLO

FDA UDI
STRYKER CORPORATION·07613327576672·3mm Straight Shaver Blade

COMBITRANS MONITORING SETS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

MULTIFUNCTION ENDOSCOPIC INSTRUMENT

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

PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code KWI·January 25, 2017

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

UNK

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 23, 2014

8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

TRILOGY EVO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·November 24, 2025

22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 26, 2013

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026