22 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Range/Denali/Mesa Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637857·CoRoent Ant TLIF PEEK, 15x10x32mm 15°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V
DD base P HI
FDA UDI
Dental Direkt GmbH·EDDIK503251·DD medical polymers (PMMA), made from PMMA, are...
AngioSystems Tray
FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026397·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820021·Marina Dissector, Concave Shovel Tip, Curved Sh...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100110·FEASTER SPECULUM SOLID WIDE
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756250184·THERA-BAND® EXERCISE BAND
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 27, 2023
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197399401·Tebbet Breast Retractor
150x25...
Capsule Polishers
FDA UDI
AURORA SURGICAL, LLC·08175700153065·Kraff Capsule Polisher, 25g, Irrigation Port in...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2021
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·June 21, 2019
IHEARTEST
FDA Adverse Event
Malfunction
·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
CASHMERE 14 - PLATINUM MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·June 6, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
FDA Enforcement
Class II
·Ongoing·Medtronic Inc·January 21, 2026