92 results · 35ms · Sources: EU EUDAMED, US FDA

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InPen System

FDA 510(k)
FDA Class 2 ·Anesthesiology

AGXO

FDA UDI
Oticon A/S·05707131353580·G400 S, MINIRITE T 312 2.4G C044 AGXO

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383511254·"An absorbent paper points is an endodontic pap...

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code OLO·June 7, 2017

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

FDA Enforcement
Class II ·Terminated·Mako Surgical Corporation·July 26, 2017

DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

FDA 510(k)
FDA Class 2 ·General Hospital

AART PECTORALIS IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDS·March 28, 2014

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDS·March 28, 2014

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 31, 2014

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 28, 2014

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 26, 2014

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013

ITREL 3

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 3, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·December 21, 2015

UNKNOWN COONRAD-MORREY ULNAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDC·February 14, 2017

UNKNOWN COONRAD-MORREY IMPLANT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDC·February 14, 2017

UNKNOWN COONRAD-MORREY IMPLANT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDC·February 14, 2017