21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E.N.S.I. SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PROTOCO2L INSUFFLATION SYSTEM
FDA Adverse Event
Injury
·E-Z-EM, INC.·Product code FCX·April 12, 2013
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·March 30, 2011
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 2, 2008
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
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
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
3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
FDA Adverse Event
Injury
·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 14, 2022
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024