16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rhythmia HDxTM Mapping System
FDA 510(k)
FDA Class 2
·Cardiovascular
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015486·2.4mm x 38mm Cannulated Lag Screw
SHAFT FOR 90 SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 24, 2020
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070904·Cannulated 2.4 x 38mm Lag Screw Sterile Qty 5
PRIMALOK FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ZIEHM SOLO
FDA 510(k)
FDA Class 2
·Radiology
OSTEOMED LDA CANNULATED SCREWS
FDA Adverse Event
Other
·OSTEOMED L.P.·Product code HWC·June 14, 2007
SHAFT FOR 90 SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 24, 2020
SHAFT FOR 90 SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 24, 2020
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2011
ENDO GIA ROTICULATOR 45-4.8 SULU
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·October 7, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
SHAFT FOR 90 SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·March 24, 2021
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
FDA Enforcement
Class II
·Terminated·Clinical Innovations, LLC·December 16, 2020
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018