24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV
QiF Blood and Fluid Warmer
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575340·CoRoent Ant TLIF Ti, 15x10x40mm 4°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239326·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811791·Viterbo Dissector, Right, 120 mm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE
ASCENDX VCF REDUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104644·FULL RADIUS BLADE, 3.5MM, S
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102657·DISPOSABLE ARTHROSCOPIC 3.5mm FULL RADIUS SHAVE...
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 25, 2009
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 31, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 8, 2011
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 5, 2008
1.0MM TI T-PLATE 5 X 7 HOLES
FDA Adverse Event
Injury
·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HRS·January 8, 2018
1.0MM TI T-PLATE 5 X 7 HOLES
FDA Adverse Event
Injury
·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HRS·January 8, 2018
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·December 14, 2015
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016