21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SalivaMAX
FDA 510(k)
FDA Unclassified
·Unknown
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756669818·POST-OP SHOE
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508802·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100387·MURDOCH EYE SPECULUM #2
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
PASS ANTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNI-THREAD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 3, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
EXCEL CONSOLE WITH FOOTSWITCH EACH1
FDA Adverse Event
Malfunction
·INTEGRA, TULLAMORE·Product code LFL·June 22, 2011
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
VAPR COOLPULSE90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·August 18, 2020
VAPR COOLPULSE90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·September 3, 2020
VAPR COOLPULSE90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·August 18, 2020
VAPR COOLPULSE90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·September 3, 2020
TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
FDA Recall
Terminated
·Kerr Corp·Product code EMA·August 14, 2006
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014