12 results · 20ms · 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.

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033479·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...

PS CONSTRAINED INSERT XLG

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017

COMPLETE BRAND MULTI-PURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

U-SYSTEMS ULTRASOUND SYSTEM USI-2000

FDA 510(k)
FDA Class 2 ·Radiology

CRYOSURGICAL, ACCESSORIES

FDA Adverse Event
Injury ·GALIL MEDICAL LTD.·Product code GEH·May 11, 2021

UNKNOWN IMPLANTABLE CATHETER

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 3, 2013

UNKNOWN ZIMMER KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·March 24, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·April 23, 2008

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

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