44 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CUBEScan BioCon-1100
FDA 510(k)
FDA Class 2
·Radiology
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50
ESCAPE CONTROL MODULE
FDA 510(k)
FDA Class 2
·Physical Medicine
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SILTEX SALINE CONTOUR MAMMARY PROSTHESIS
FDA Adverse Event
Injury
·MENTOR·Product code FWM·July 2, 1998
DELTA SHUNT ASSEMBLY, REGULAR, PERFORMANCE LEVEL 1
FDA Adverse Event
Injury
·MEDTRONIC PS MEDICAL·Product code JXG·May 18, 1998
57E2 HANDPIECE
FDA Adverse Event
Other
·MICRO-MEGA·Product code EFB·August 29, 2002
CRYOVALVE
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·October 9, 1998
CRYOVALVE
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·July 27, 1998
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
METASUL DUROM, COMPONENT FOR ACETABULUM, SIZE 52
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·June 26, 2013
ZYVEK ENTERALITE INFINITY FEEDING PUMP
FDA Adverse Event
Malfunction
·ZYVEK·Product code LZH·August 5, 2011
UNKNOWN SALINE IMPLANTS
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 24, 2019
UNKNOWN SALINE IMPLANTS
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 24, 2019
IPP INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·August 29, 1997
CHARGER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·January 30, 2020
ALPHA I INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·October 17, 1997
(5) DENTAL AMALGAM IN 5 MOLARS
FDA Adverse Event
Death
·UNK·Product code EJJ·June 16, 1998
ELECTRIC DERMATOME HANDPIECE
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code GFD·April 30, 2015
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·July 18, 2019