20 results · 34ms · 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.

Yomi Robotic System

FDA 510(k)
FDA Class 2 ·Dental

Symmetry Cone

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001257·Symmetry® Curette, Cone Ring, Angled, Size 3, 9...

Advantage Trial Inserter

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067915·

Encision AEM enTouch 2X Scissor

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AUTOGEL PAD

FDA 510(k)
FDA Class 2 ·Radiology

IMP,TSV,4.1MM,SBM,8

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 31, 2020

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2012

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2012

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 15, 2014

SILICONE ADVANCED OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·October 28, 2008

OCTRODE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014

LASSOSTAR NAV CIRCULAR MAPPING CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·October 19, 2023

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019