15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GESCO
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H67140700170·MICRO-FORCEP
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690163·Advanced Dental Implant Ø3.75mm L8mm
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114690102·Multi-Unit Screw for Angulated NP L5mm
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690378·Straight Ball Abutment Internal Hex. SP H1mm
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 9, 2025
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
FDA 510(k)
FDA Class 2
·General Hospital
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 15, 2015
CORTSCR Ø4.5 L30 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·April 22, 2013
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·July 2, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 26, 2011
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021