18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hospira Primary Sets
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550209·GENUMEDI PT KNEE SUP SILVER R EW V
SENTRI INTERSURGICAL ECOLITE ADULT MASK WITH CO2 MONITORING LINE FILTER AND TUBE
FDA UDI
Intersurgical Incorporated·05030267111954·SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH ...
LEONE SPA
FDA UDI
LEONE SPA·08033707011736·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 15
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM1430150·Medium 15-Degree 3DP LLIF - 14mm x 30mm
Apache
FDA UDI
Genesys Orthopedics Systems LLC·M719GLLTIL1430150·Large 15 DEG Titanium LLIF
Apache
FDA UDI
Genesys Orthopedics Systems LLC·M719GLLTIM1430150·Medium 15 DEG Titanium LLIF
3L SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ODRC-DYNAMIC HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·June 6, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 21, 2015
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 3, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 23, 2011
da Vinci S / Si Surgical System IS2000 / 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 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