30 results · 23ms · 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.

S4 SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REMEL

FDA UDI
REMEL, INC.·00848838008672·PYR Broth (0.5ml) 20/PK

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036026127·

SOMNO STAR & SERIES SLEEP SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ULTRASOUND SCANNER, TYPE 1101

FDA 510(k)
FDA Class 2 ·Radiology

BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 24, 2021

CONTOUR®

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012

BREEZE2

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015

BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 16, 2021

CONTOUR NEXT

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014

CONTOUR

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019

CONTOUR® TS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 16, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

HEARTMATE XVE LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·June 16, 2008

SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 22, 2021

CONTOUR® TS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025

CONTOUR® TS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR®

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025