12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
FDA 510(k)
FDA Class 2
·Orthopedic
Conmed/Linvatec
FDA UDI
Provision·B504OM50921240·
Conmed/Linvatec
FDA UDI
Provision·00810041066404·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123106·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 100mm
GALEMED PEAK FLOW METER, MODELS 3751/3752
FDA 510(k)
FDA Class 2
·Anesthesiology
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·May 3, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 27, 2011
PUMP MMT-512NAS PRDGM INSULIN SK EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 31, 2008
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·November 20, 2013
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012