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