17 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISTA BRITE TIP CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-BR2000 LARGE BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919095453·KM71-572
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
PATIENT MONITORS MODELS 78701A/78702A
FDA 510(k)
FDA Class 2
·Cardiovascular
HUDSON NASAL PREFORMED TARHCEAL TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·January 31, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·January 25, 2011
UNKNOWN DEPUY SZ 4 FB TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code JWH·July 31, 2014
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 22, 2025
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 5, 2022
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 16, 2022
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 24, 2022
CAPIOX FX05 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DTZ·May 19, 2023
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 29, 2022
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 14, 2022
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·October 2, 2013