10 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.

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)

3M™ Victory Series™

FDA UDI
3M UNITEK CORPORATION·00652221112446·3M™ Victory Series™ First Molar Bands, 902-475,...

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

FDA 510(k)
FDA Class 2 ·Orthopedic

REPLACE TPS COATED IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

MECHANICAL CHAIR/TRANSPORT CHAIR

FDA Adverse Event
GOODBABY·Product code INM·January 8, 2013

ST104 TRANSPORT

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