11 results · 19ms · 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.

LANDERS VITRECTOMY LENS RING W/INFUSION

FDA 510(k)
FDA Class 1 ·Ophthalmic

N/A

FDA UDI
Smith & Nephew, Inc.·00885556076231·SMALL BLADE FOR INITIAL INCISION ...

TITAN PLUG SCREW 8MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002

ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

MODEL 4815 ADAPTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

COPRAN ZR/ORIGIN YZ

FDA 510(k)
FDA Class 2 ·Dental

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·May 7, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 8, 2013

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·November 12, 2010

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