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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EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033250·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
Flex
FDA UDI
Diversified Products, Inc.·00842894158746·
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
FMP METAL/METAL ACETABULAR INSERT
FDA 510(k)
FDA Class 3
·Orthopedic
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 14, 2022
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·April 3, 2013
SCREW,2.4X12MM CANCELOUS LOCKNG
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·March 30, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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