9 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.

VITALSENSE

FDA 510(k)
FDA Class 2 ·General Hospital

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033534·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

PENTRA 5D

FDA 510(k)
FDA Class 2 ·Hematology

SELF-COUNTERSINKING BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

HOMECHOICE

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

SPINAL CORD STIMULATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 24, 2011

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 25, 2014

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