16 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.

NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE

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

NA

FDA UDI
STERILMED, INC.·10888551020459·SAW BLADE OSCILLATING LARGE BONE

Up&Up

FDA UDI
TARGET CORPORATION·00014007478779·Black Pre-Cut Kinesiology Tape - 2in x 10in - U...

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

FDA 510(k)
FDA Class 2 ·Hematology

CADENCE PHYSIO QC ADULT RTS

FDA Adverse Event
Malfunction ·COVIDIEN·Product code MLN·April 8, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

FREESTYLE INSULINX

FDA Adverse Event
Malfunction ·Product code NBW·April 10, 2013

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

FDA Enforcement
Class I ·Terminated·Abbott Diabetes Care, Inc.·May 15, 2013

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

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