47 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
FDA 510(k)
FDA Class 2
·Hematology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036771·FPS 2.7mm Screwdriver Sleeve
N/A
FDA UDI
Smith & Nephew, Inc.·00817470003482·SPEEDLOCK PLUS KIT BLUE COBRAID SUTURE
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369573·RING PAD LARGE
OEC 9800 PLUS
FDA 510(k)
FDA Class 2
·Radiology
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PULSAVAC
FDA Adverse Event
Malfunction
·ZIMMER BIOMET/ZIMMER SURGICAL, INC.·Product code FQH·December 11, 2024
ONESTEP
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 27, 2026
ONESTEP
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 27, 2026
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2026
DOSI-FUSER
FDA Adverse Event
Malfunction
·EPIC INTERNATIONAL (THAILAND) CO., LTD.·Product code MEB·December 8, 2025
LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·September 13, 2022
UNKNOWN MESH PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code FTL·November 6, 2014
OPTIMA MAX, 130K ULTRACENTRIFUGE, 120V
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JQC·September 1, 2011
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 17, 2013
FUSTON SPHINCTEROTOME 7F 25MM 175CM
FDA Adverse Event
Malfunction
·COOK INCORPORATED·Product code KNS·June 20, 2025
FUSTON SPHINCTEROTOME 7F 25MM 175CM
FDA Adverse Event
Malfunction
·COOK INCORPORATED·Product code KNS·June 20, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 14, 2023
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026