31 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HHM
FDA UDI
Oticon A/S·05707131164537·K130, BTE 13 CBE HHM
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094070194·Welch Allyn CardioPerfect Workstation with PC-B...
AIM™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868003608·
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707060237·.017 X .025 UPPER NITANIUM® SUPER ELASTIC OVAL ...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094336139·AM12 AHA W INTERP ABPM
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
FDA 510(k)
FDA Class 2
·General Hospital
ANSPACH EMAX DRILL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
16CM MIN. INVASIVE ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·December 10, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·April 29, 2013
CYLOS DR-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DXY·August 5, 2008
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.,·Product code MDS·May 2, 2011
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015
8CM ANGLE ATTACHMENT, BLACK, MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 30, 2020
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·December 27, 2023
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015