11 results · 37ms · Sources: EU EUDAMED, US FDA

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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