17 results · 30ms · 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.

Traumatic brain injury (TBI) test

FDA 510(k)
FDA Class 2 ·Immunology

ASO Speed Lacer Ankle Stabilizer

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236022·

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551077719·Micro Mirror, diameter 5 mm, 16 cm

CASCADIA™ Interbody System

FDA UDI
VB Spine LLC·10888857312609·AN Lordotic - Oblique Inserter 10 mm

TM ARDIS INTERBODY SYSTEM INSERTER

FDA 510(k)
FDA Class 2 ·Orthopedic

SMALL VOLUME NEBULIZER

FDA 510(k)
FDA Class 2 ·Anesthesiology

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857235458·Hook Trial Size 6 mm

REXEED SERIES DIALYZERS

FDA Adverse Event
Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·October 30, 2014

GALILEO

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·August 25, 2011

MONOCRYL PLUS SUTURE

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code GAM·July 12, 2013

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026