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

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FastFrame External Fixation System-Ankle Spanning

FDA 510(k)
FDA Class 2 ·Orthopedic

SSW CARBIDE TRIMMING AND FINISHING

FDA UDI
Ss White Burs, Inc.·D6901527552·20 BLADE FINISHING CARBIDE 8274 - 5 PACK

CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER

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

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

FDA 510(k)
FDA Class 2 ·Cardiovascular

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 8, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MPRI·Product code NVY·June 8, 2013

BD LUER-LOK¿ TIP SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 20, 2023

VENATECH CONVERTIBLE

FDA Adverse Event
Malfunction ·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014