12 results · 21ms · 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.

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

FDA 510(k)
FDA Class 2 ·Microbiology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032738·Baltic Denture System BDLoad Ln6 PLSEbil2DFl BL...

BAYER RAPIDPOINT 400 SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYMPHONY GRAFT DELIVERY SYSTEM (GDS)

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

FLEXI-SEAL FMS

FDA Adverse Event
Other ·CONVATEC·Product code KNT·June 7, 2006

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 3, 2013

SET, A.V. FISTULA NEEDLE, WING EATER SAFETY 15 G. JMS

FDA Adverse Event
Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FIE·February 18, 2011

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·August 25, 2014

FLEXI-SEAL FECAL MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024