23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
FDA 510(k)
FDA Class 2
·Orthopedic
APEX Base - Opaque Original Pink - 3kg
FDA UDI
Sprintray, Inc.·00850070544443·SprintRay Apex Base resin is a light-curable po...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112892·CORNEAL TREPHINE BLADE7.0MM
TREATVISION
FDA 510(k)
FDA Class 2
·Radiology
TRAXX ELECTRIC WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
BD¿ THIN WALL 31G X 5MM VALUE BRAND
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 2, 2022
VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·July 22, 2021
ANGIOGUARD RX
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·October 16, 2008
REPLY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code NVZ·June 28, 2013
OHMEDA INTERMITTENT SUCTION UNIT
FDA Adverse Event
Malfunction
·OHMEDA MEDICAL·Product code KDP·August 5, 2011
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 11, 2021
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURER·Product code FWM·January 11, 2022
MEDTRONIC NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 31, 2023
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·September 7, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 10, 2023
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 9, 2025
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·January 30, 2026
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017