13 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.

HemosIL Factor V Leiden (APC Resistance V)

FDA 510(k)
FDA Class 2 ·Hematology

Milling Blank

FDA UDI
BICON, LLC·00813110028617·10mm UA5 Milling Blank - 2.5mm Post

LEONE SPA

FDA UDI
LEONE SPA·08033707097754·ABUTMENT TI-BASE FOR EXACONNECT

Milling Blank

FDA UDI
BICON, LLC·00813110029324·10mm UA5 Milling Blank - 2.5mm Tall Post

BRIVANT GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

VALO Grand

FDA 510(k)
FDA Class 2 ·Dental

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2011

MONOPOLAR CURVED SCISSORS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 1, 2013

PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

MECTALIF TRANSFORAMINAL CAGES TIPEEK

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021