17 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.

FlexWing Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

BD BBL™ Sensi-Disc™ Minocycline 30 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312513·BD BBL™ Sensi-Disc™ Minocycline 30 µg

SPROTTE® 2.G

FDA UDI
Pajunk GmbH Medizintechnologie·14048223024239·SPROTTE® 2.G Standa...

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573021437·INTRG WHISP MBT CUS HK 0T +3A 018 LR

SPROTTE®

FDA UDI
Pajunk GmbH Medizintechnologie·04048223108222·Distal Tip: SPROTTE® Proximal End: ISO 80369-7

Rx Knee Femoral Cone Augment Reamer Size Medium

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147822·

CarboClear Navigated Instruments

FDA 510(k)
FDA Class 2 ·Neurology

TRINITY ELE

FDA 510(k)
FDA Class 2 ·Neurology

RELION INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 30, 2020

UNKNOWN DELTA VALVE

FDA Adverse Event
Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 15, 2011

GE OEC 9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

CUB PEDIATRIC CRIB- HYD BASE

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FMS·July 17, 2013

BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025