12 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HALO ABLATION CATHETER, MODEL 90-9100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
UNIVERSAL SYSTEM, MODEL QV-800
FDA 510(k)
FDA Class 2
·Radiology
NEXUS 2 MODIFIED
FDA 510(k)
FDA Class 2
·Dental
AMISTEM H FERMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 30, 2012
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 3, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 3, 2011
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