19 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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PRECISION LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471003·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470969·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470990·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470952·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470983·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470945·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089471010·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470921·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470976·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089470938·
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
FDA 510(k)
FDA Class 2
·Anesthesiology
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 8, 2013
INRATIO PT/INR TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 14, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018