53 results · 31ms · Sources: EU EUDAMED, 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