53 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpaceOAR System
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XPS 3000 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 19, 2021
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·April 26, 2019
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JWH·August 17, 2022
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·November 8, 2022
ANGIO-SEAL
FDA Adverse Event
Death
·Product code MGB·October 15, 2008
PARADYM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code MRM·June 28, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·August 1, 2024
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·August 1, 2024
INTERA 3000 HEPATIC ARTERY INFUSION PUMP
FDA Adverse Event
Malfunction
·INTERA ONCOLOGY·Product code LKK·July 8, 2022
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 20, 2022
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·May 31, 2022