26 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FDA Adverse Event
FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017
Sledgehammer
FDA UDI
Keystone Industries·H66810004711·HC 1 lb Pwd & 8 oz Liq Kit, Orig
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282503284·TeWa CJ-Type 4015 (s): uncoated acupuncture ne...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117354·NobelBiocare™ Tri-Lobe-compatible NP Esthetic A...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004710·
MASEL Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707102319·BT 018 ROTH MINI SGL L7R DB (10)
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·Product code FPA·May 20, 2024
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004710·
CBYON SURGICAL OPERATING SYSTEM (SOS)
FDA 510(k)
FDA Class 2
·Neurology
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
EVIS EXERA II COLONOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDF·November 22, 2024
17G WALLACE SINGLE LUMEN OOCYTE RECOVERY SET
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code MQE·October 25, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 12, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·February 21, 2008
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016