10 results
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20ms
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Sources: EU EUDAMED, US FDA
Ortholock Anchorage Devices
FDA 510(k)
FDA Class 2
·Dental
Cal OSHA - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383513463·"An absorbent paper points is an endodontic pap...
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Single-Use Surgical Mask With Ear Loop
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IEON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 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