11 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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VOLAR RADIUS PLATE WITH ANGULAR STABILITY
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033756·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
FDA 510(k)
FDA Class 2
·Dental
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
FDA 510(k)
FDA Class 2
·Ophthalmic
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
DIMENSION VISTA®
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018
EXPLOR 14X22MM IMPLANT HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWI·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 17, 2011
30327 3CC 100 UNIT HEP SYR {CAN} (2.5CC)
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code NZW·April 23, 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