10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CELLO II Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
V-Strap Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232758·
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
FDA 510(k)
FDA Class 2
·Immunology
Recon Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·August 16, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 4, 2014
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018