17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ABL90
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Bernafon AG·05711584005965·CT9 N, PS SF MAC CANTEO 9
NORIAN SRS BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
CORTEX CO2 / ER:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOSIS,PEDICLE SPINAL FIXATION
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·December 8, 2015
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 2, 2011
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·August 12, 2008
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
PLATE ADAPTER DIST. LAT. FEMUR RIGHT
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·May 11, 2017
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 25, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021