10 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033259·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
FDA 510(k)
FDA Class 2
·Ophthalmic
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
FDA 510(k)
FDA Class 2
·Microbiology
PROXIMATE** LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 3, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 30, 2011
PROFEMUR(R) XM STEM
FDA Adverse Event
Death
·MICROPORT ORTHOPEDICS INC.·Product code KWA·August 25, 2014
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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021