15 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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OSTEOGEN SBRG
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033098·Baltic Denture System BDLoad Sw7 PLSEbm6DFs D4 ...
INSTANT-VIEW Morphine/Opiates (300) Urine Dip-Strip Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000542·INSTANT-VIEW Morphine/Opiates (300) Urine Dip-S...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
KIMAX REMOTE VIEWING STATION
FDA 510(k)
FDA Class 2
·Radiology
ACCESS ULTRASENSITIVE HGH CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAD-5V HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 10, 2015
PARIETEX
FDA Adverse Event
Injury
·Product code OTP·January 5, 2015
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 3, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·February 28, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 22, 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