24 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SEA-LINK Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529000922·A single-use fiberoptic accessory intended for ...
OPERATING SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054592·OPERATING SCISSORS CURVED BLUNT TIPS POWER CUT ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006347·Rigid Nose Mini Plate Benders
FLUROPERM 60-OK, PARAGON HDS-OK
FDA 510(k)
FDA Class 2
·Ophthalmic
ESTECH COBRA BIPOLSR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 23, 2022
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 29, 2016
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 16, 2020
DRILL, 1.5X105MM, 22MM STOP, J NOTC
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code HTW·October 2, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 1, 2013
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 30, 2019
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 22, 2016
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBF·December 7, 2023
NEEDLE 25GA 1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·August 27, 2021
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY·Product code MOZ·April 25, 2013
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024