14 results · 22ms · 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.

XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML

FDA 510(k)
FDA Class 2 ·Dental

BENCO

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975057037·

UNKNOWN COBLATION DEVICE

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code GEI·January 30, 2024

A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM

FDA 510(k)
FDA Class 2 ·Dental

EVA DIGITAL DENTAL X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

PEN NDL 31GA 8MM 100 BX 1200 USA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 13, 2024

PEN NDL 31GA 8MM 100 BX 1200 USA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 29, 2024

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013

12.4 CM HEAVY DUTY LONG ATTACHMENT

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 30, 2014

MAXIMO VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

VERCISE GENUS?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·April 30, 2025

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Enforcement
Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019