19 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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Magic3 Go Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637871·CoRoent Ant TLIF PEEK, 15x10x34mm 15°
AGXO
FDA UDI
Oticon A/S·05707131287496·H110V2, MINIRITE 312 WL TC AGXO
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803864·Conrad Separator, 20cm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 17, 2023
CIE FOLDAWAY WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SYSTEMS INTEGRATION MODEL: ENDOALPHA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MINILINK TRANSMITTER
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·October 7, 2014
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 6, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024