14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034004440·ISOLA SPINE SYSTEM CLOSED BODY-NO ROD 6.35mm
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517151107·
CHARNLEY OGEE CUP 22.225/40MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 13, 2004
MICROPOBE SERIES OF LASERS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
FDA 510(k)
FDA Class 2
·Ophthalmic
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·February 28, 2012
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2014
SYNFIX LR 26MM DEPTH/32MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MAX·April 16, 2008
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
Spirit One A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024