10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE INTRODUCER SHEATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Tecomet
FDA UDI
TECOMET INC.·00841435108271·ARTHROPASSER NEUTRAL
SPPHINE PLUS STM 3W DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 6, 2012
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 11, 2013
INTERSTIM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 24, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024