11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PERIOGRAF
FDA 510(k)
FDA Class 2
·Dental
Sphero Attachments
FDA UDI
Preat Corporation·00842092125427·Sphero Block Abutment Nobel Active/Conical NP x...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130700·Drill Bit, 1.5mm diam., 4.5mm
Portex
FDA UDI
ICU MEDICAL, INC.·15019517077209·
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
FDA 510(k)
FDA Class 2
·Cardiovascular
JAMSHIDI BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 15, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025