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.

CORING NEEDLE (TREPHINE, ORTHOPEDIC)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

EDENTA

FDA UDI
EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm

TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES

FDA 510(k)
FDA Class 2 ·General Hospital

SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code INK·November 12, 2010

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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