20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISULUX
FDA 510(k)
FDA Class 2
·Ophthalmic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528102114·5.6 mm Cannulated Over Drill, Standard AO Quick...
Orthocryl®
FDA UDI
DENTAURUM GmbH & Co.KG·J011161607000·Orthocryl® Disco glitter, blue
OsteoMed
FDA UDI
OSTEOMED LLC·00842528108253·5.6 mm Cannulated Over Drill, Standard AO Quick...
BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
STORM OPERATING KIT, MODEL 1-10-0
FDA 510(k)
FDA Class 2
·Orthopedic
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Injury
·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Death
·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025
HILL-ROM
FDA Adverse Event
Malfunction
·HILL-ROM·Product code FPO·June 5, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 14, 2011
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
VERSAFITCUP CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·January 5, 2017
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018