11 results · 20ms · 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.

Access Folate Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GLOBAL CAP CTA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105565·GLOBAL C.A.P. CTA CTA PIN 2.4 X 42mm

POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

FDA 510(k)
FDA Class 1 ·General Hospital

ACROBAT CALIBRATED TIP WIRE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code OCY·August 5, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

TELIGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117

FDA Recall
Open, Classified ·Prismatik Dentalcraft, Inc.·Product code NHA·September 30, 2025

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 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