12 results · 20ms · Sources: EU EUDAMED, US FDA

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ISOLA SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033449011·

MTG - MINITUB HEATED STAGE SYSTEMS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

FDA 510(k)
FDA Class 2 ·Neurology

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2022

4-CH DBS EXTENSION KIT, 50CM

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code MHY·June 19, 2025

UNK BACTISEAL CATHETER

FDA Adverse Event
Injury ·Product code JXG·November 20, 2017

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 1, 2013

MBT POR KEEL TIB TRAY SZ5

FDA Adverse Event
Injury ·DEPUY (IRELAND)·Product code NJL·February 24, 2011

TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·March 13, 2008

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

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025