15 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.

POWER TEK II

FDA 510(k)
FDA Class 2 ·Orthopedic

Safco DENTA-SAFE DENTAL DAM

FDA UDI
SAFCO DENTAL SUPPLY CO.·20810063750217·Heavy (0.23mm-0.28mm thickness) 5" x 5", green,...

SPL-50 SPIROLYSER

FDA 510(k)
FDA Class 2 ·Anesthesiology

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PACKING COIL LP

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·September 17, 2021

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·March 26, 2013

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·March 16, 2011

9611369-2008-00149

FDA Adverse Event
Malfunction ·Product code KDI·February 20, 2008

OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - 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

OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

IMP,TSV,3.7,13,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 17, 2022

IMP,TSV,3.7,10,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·September 8, 2022

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