12 results · 20ms · Sources: EU EUDAMED, 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