11 results
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37ms
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Sources: EU EUDAMED, US FDA
MAXIFLEX-SEMI FLEX SCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HairCheck-DT (Opiates)
FDA UDI
Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...
MICROPAQ, MODELS 402 AND 404
FDA 510(k)
FDA Class 2
·Cardiovascular
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONSERVE(R) TOTAL A-CLASS HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·April 17, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 17, 2008
TROCHANTERIC NAIL KIT, TI 11X200MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·April 13, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code GJS·August 10, 2020
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015