16 results · 21ms · 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.

INTEGRATED INNOVA - S5I SYSTEM OPTION

FDA 510(k)
FDA Class 2 ·Radiology

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...

Biliary Drainage Tube

FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046865·

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0112090·Tap, Cannulated, 7.5 mm

MANAN SPRITACRE SPINAL NEEDLES

FDA 510(k)
FDA Class 2 ·Anesthesiology

ACRYLIC HERBST APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

NGAGE NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code FFL·November 13, 2018

VITEK® 2 AST-ST01 TEST KIT

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE·Product code KDJ·September 23, 2014

KAPPA 900 DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code DXY·June 2, 2011

PANTHER FUSION ADV/HMPV/RV ASSAY

FDA Adverse Event
Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

FDA Adverse Event
Malfunction ·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021

SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

FDA Enforcement
Class II ·Terminated·Monteris Medical Corp·November 26, 2014

ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026