16 results · 31ms · 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.

REPROCESSED TROCARS

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

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699937·Bone Tap for Ø5mm Implant

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690729·Titanium Anatomic Angulated Concave Abutment In...

ENGPLUS

FDA 510(k)
FDA Class 2 ·Neurology

MFCD 118I

FDA 510(k)
FDA Class 2 ·Radiology

PEN NDL 32GA 4MM 14BAG 700CASE JP

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 15, 2020

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2024

SPECTRA WAVEWRITER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 6, 2025

PEN NDL 32GA 4MM 14BAG 700CASE JP

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 13, 2021

BD MICRO FINE PLUS INSULIN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 5, 2021

ASR TAP SLV ADAP 12/14 -1

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 22, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 26, 2011

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 3, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024