14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REDSENSE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
KEY SURGICAL, INC.·00849771048213·K-Wire and Steinmann Pin Dispensers, .045-inch...
K-Wire and Steinmann Pin Dispensers
FDA UDI
KEY SURGICAL, INC.·00849771012030·K-Wire and Steinmann Pin Dispensers, .045-inch...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100050·EVOS Curved HA PEEK 13mm x 10mm x 30 mm,Biconve...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR30710131·Set for uprighting spring with cross tube .022"
Imola-Silverstone
FDA UDI
Altus Spine, LLC·00843210133959·SS Paddle Distractor 13mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0110130·Sounder, Ball Tip, Straight, Soft, Titanium
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
FDA 510(k)
FDA Class 2
·Neurology
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
FDA 510(k)
FDA Class 1
·General Hospital
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
RAPIDPOINT 500
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKR·April 11, 2013
UNKNOWN PRODUCT - CUP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWB·April 20, 2011
PROTOS DR/CLS
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.,·Product code DXY·July 2, 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