10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Medicom Midnight
FDA UDI
AMD Medicom Inc·10686864058943·Medicom Midnight - Procedure Earloop Face Masks...
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5
LUTZ NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
MEPILEX TRANSFER AG
FDA 510(k)
FDA Unclassified
·Unknown
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
XENIUM XPH
FDA Adverse Event
Injury
·NIPRO CORPORATION *USD*·Product code KDI·August 17, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·July 3, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021