10 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.

ABBOTT TESTPACK PLUS TM HCG-COMBO

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Map-iT

FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020152·Fixed Curve Decapolar Catheter with Guidewire Tip

HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

FDA 510(k)
FDA Class 1 ·Dental

STERRAD SEALSURE CHEMICAL INDICATOR TAPE

FDA 510(k)
FDA Class 2 ·General Hospital

BD PLASTIPAK 50ML LUER-LOK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 23, 2019

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 30, 2014

GOLVO

FDA Adverse Event
Malfunction ·LIKO AB·Product code FSA·January 2, 2013

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·November 12, 2010

HARMONIC SCALPEL HAND PIECE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 26, 2024

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