11 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LUMEND FRONTRUNNER CTO CORONARY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm

QUICK SET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 20, 2026

LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)

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

PHLEBOPUMP, MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

RX ACCULINK CAROTID STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIM·July 12, 2013

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·March 20, 2013

INJECTOR, OPTIVANTAGE DH W/RFID

FDA Adverse Event
Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011

AFFINITY BED

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code HDD·March 14, 2008

SINGLE USE BIOPSY VALVE (STERILE)

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code EOQ·July 26, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012