16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV
CRILE-WOOD NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075887·CRILE-WOOD NEEDLE HOLDER STRAIGHT TUNGSTEN CARB...
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDONIC CA620/530 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
ENDO FLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 1, 2013
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 14, 2011
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 23, 2019
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 23, 2019
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 23, 2019
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021