18 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACTIVE ANDROSTENEDIONE EIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004857·
SURGISTAR, INC.
FDA UDI
SURGISTAR, INC.·00878799001535·
Acrometrix HCV Mid Control
FDA UDI
Microgenics Corporation·00884883006461·
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660200197·30 degree stab blade, straight blade, screw-in ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190561·A/P Sizing and Distal Cutting Block 6deg Drill...
EDP-5 INVIVO Detector
FDA UDI
IBA Dosimetry GmbH·EIBA9630020·EDP-5 3G-pSi Semiconductor detector, 2m cable
Nx Drill Accessory Kit
FDA UDI
Eca Medical Instruments·00857676008447·1.75mm NX Drill
Kangaroo Feeding Tube with IRIS Technology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALTRA PRESS-FIT HIP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 13, 2024
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code NVY·July 31, 2015
ARTHROCARE SUPER TURBOVAC 90
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code GEI·January 13, 2011
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·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
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024