13 results
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26ms
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Sources: EU EUDAMED, US FDA
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502501·MR-Adapter for GE Quadrature Head Coil
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101321·SS Suture, 6 per sleeve
Alteon
FDA UDI
Exactech, Inc.·10885862606624·
LIFESTYLE OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
STA-QUALITY HBPM/LMWH KIT
FDA 510(k)
FDA Class 2
·Hematology
ASR ACETABULAR IMPLANT 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 8, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 15, 2011
LASIK
FDA Adverse Event
Injury
·Product code LZS·May 7, 2008
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
FDA Enforcement
Class II
·Ongoing·Quest International, Inc.·September 17, 2025
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018