19 results
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19ms
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Sources: EU EUDAMED, US FDA
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
Acrometrix HCV Low Control
FDA UDI
Microgenics Corporation·00884883006454·
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004819·
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799003768·
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660200180·30 degree stab knife, straight NexGen blade, fu...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190578·A/P Sizing and Distal Cutting Block 5deg Drill...
Sklar®
FDA UDI
SKLAR CORPORATION·50649111133884·GRAVES VAG SPEC MED STRL 50/CS
Nx Drill Accessory Kit
FDA UDI
Eca Medical Instruments·00857676008430·1.5mm NX Drill
SYSTEM 2450
FDA UDI
Conmed Corporation·10653405054870·SYSTEM 2450 STACKING ADAPTER
SYSTEM 2450
FDA UDI
Conmed Corporation·20653405054877·SYSTEM 2450 STACKING ADAPTER
PowerFlow Apheresis I.V. Port
FDA 510(k)
FDA Class 2
·General Hospital
SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYHESIVE II RETURN ELECTRODE
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·January 23, 2013
*
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·January 5, 2011
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 29, 2014
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
FDA Recall
Open, Classified
·Sklar Instruments·Product code HDF·December 3, 2024
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018