12 results · 36ms · Sources: EU EUDAMED, US FDA

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INSTRUMENT, ULTRASONIC, SCALPEL

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

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006

HealthPNX

FDA 510(k)
FDA Class 2 ·Radiology

IMAG, IPOD, EZ-FIND AND ISLIDE

FDA 510(k)
FDA Class 2 ·Ophthalmic

COULTER® ACT DIFF 2 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC·Product code GKZ·December 7, 2010

ASR ACETABULAR IMPLANT 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·March 5, 2013

SPRINT FIDELIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 7, 2014

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025