19 results · 19ms · Sources: EU EUDAMED, US FDA

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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

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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