14 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.

BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RAM®

FDA UDI
LSI Solutions, Inc.·00850200006667·RAM® DEVICE, 5MM

nSpire Health

FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...

PRAIRIE CRUISER

FDA 510(k)
FDA Class 2 ·Physical Medicine

ERCHONIA PL2000

FDA 510(k)
FDA Class 2 ·Physical Medicine

AO LARGE REAMER ATTACHEMNT

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code HWE·October 23, 2023

UNK ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·March 27, 2013

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011

PRECISION XTRA / OPTIUM

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 1, 2008

M2A-MAGNUM PF CUP 52ODX46ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 25, 2023

STOCKERT CORONARY PERFUSION CANNULAE

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

CUST 32MM FRDM LNR SZ22 +5MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·November 23, 2021

BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 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