99 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S8 ASPEN WITH H4I PLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
BiPAP A30
FDA UDI
Respironics, Inc.·00606959039346·BiPAP A30 Ventilator with Heated Tube Humidifie...
ELBOW FIXATOR
FDA UDI
ORTHOFIX SRL·18053504364825·Component. Not for sale. Used for reporting Dir...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390849654·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026025·microSelectron Transfer Tube for Metal Needles ...
CLEARFIX RIGID STERNAL FIXATION Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089436835·
ULTRACONCENTRATOR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
FDA 510(k)
FDA Class 2
·Cardiovascular
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·January 8, 2018
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·February 15, 2022
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·November 6, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·December 15, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·November 29, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 5, 2018
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·May 18, 2023
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 25, 2022
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·March 3, 2022
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·June 29, 2022