10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cleaner Plus Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...
FDA 510(k)
FDA Class 2
·Dental
CORERESTORE 2
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 8, 2013
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021