12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz
ROCCIA
FDA UDI
Silony Medical GmbH·04054896028149·ROCCIA MultiLIF Cage 9 x 34 mm, 5° Lor.
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN MINT TINGLE BRAND LATEX CONDOMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013
ENTERRA
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LNQ·September 16, 2014
CONNECTOR TUBING BX 100
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FPA·April 12, 2011
ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
FDA Recall
Terminated
·Product code FGE·June 10, 2005
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