41 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JET PORT PLUS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Immunalysis
FDA UDI
IMMUNALYSIS CORP·00840937108925·Multi-Drug Calibrator 2
Taurus
FDA UDI
CTL Medical Corporation·00841732163775·Taurus Implant Caddy- Headbody and Set Screws
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700001250·
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520001250·Curved Ti Rod, 125mm
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132119433·ø2.5mm Flexible IM Nail Cap (2 Each)
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555244000125·Forceps Persuader, Assy.
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555500000125·Taurus Implant Caddy- Headbody and Set Screws
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700001250·
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132198155·Ø2.5 MM FLEXIBLE IM NAIL CAP (2 EACH)
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
FDA 510(k)
FDA Class 2
·Neurology
RETIC CHEX LINEARITY
FDA 510(k)
FDA Class 2
·Hematology
RENEGADE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORK·Product code DQO·March 28, 2007
RENEGADE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORK·Product code KRA·April 13, 2007
RENEGADE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORK·Product code KRA·April 13, 2007
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·February 14, 2013
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·February 3, 2011
LUGE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQX·February 19, 2008
11 HOLE LOCKING OLECRANON PLATE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·March 13, 2015
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·July 20, 2020