21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLEEPSTYLE 200 AUTO SERIES HC254
FDA 510(k)
FDA Class 2
·Anesthesiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609058·GETINGE / SHAMPAINE 4.25" SOFTCARE PLUS
CD25-PE
FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934134302·4E3 recognizes the human CD25 antigen, a 55 kDa...
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GEIGER NEEDLE ADAPTER, MODEL 406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810290150·Dwyer Calcaneal Guide, 29mm x 15mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810290160·Dwyer Calcaneal Guide, 29mm x 16mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810290140·Dwyer Calcaneal Guide, 29mm x 14mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810290130·Dwyer Calcaneal Guide, 29mm x 13mm
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 29, 2024
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 27, 2012
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 24, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·April 14, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·July 17, 2008
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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