9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033969·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...
MINIBLASTER
FDA 510(k)
FDA Class 2
·Dental
ELECSYS CA 125 II CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·March 18, 2011
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·April 24, 2008
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