10 results · 16ms · 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.

WEEVAC 1 PORTABLE RESCUE STRETCHER

FDA 510(k)
FDA Class 1 ·General Hospital

LEADER

FDA UDI
Cardinal Health 110, Inc.·00096295124033·Advanced Antibacterial Clear Waterproof Strong ...

3M™ Victory Series™

FDA UDI
3M UNITEK CORPORATION·00652221112439·3M™ Victory Series™ First Molar Bands, 902-474,...

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

FLAATZ 750E

FDA 510(k)
FDA Class 2 ·Radiology

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·July 9, 2015

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

VISIAN ICL (IMPLANTABLE COLLAMER LENS)

FDA Adverse Event
Injury ·STAAR SURGICAL CO.·Product code MTA·November 10, 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