23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOMATOM SCOPE/SOMATOM SCOPE POWER
FDA 510(k)
FDA Class 2
·Radiology
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313275·STABILITY TRIAL HUMERAL CUP 135/145° Ø40 +12
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311409120·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321409120·
Life Instruments
FDA UDI
Life Instrument Corporation·M93071409122D0·9" Micro Curette #2/0 Forward Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M93071409121D0·9" Micro Curette #2/0 Backward Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M93071409120U0·9" Micro Curette #2/0 Forward Straight
Life Instruments
FDA UDI
Life Instrument Corporation·M93071409121U0·9" Micro Curette #2/0 Forward Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M93071409120D0·9" Micro Curette #2/0 Backward Straight
Humeral Cup Stability
FDA UDI
FX SOLUTIONS·03701037314203·STABILITY TRIAL HUMERAL CUP CUSTOM MADE 135/145...
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
FDA 510(k)
FDA Class 2
·Neurology
HYDROGEL CANALICULAR PLUG
FDA 510(k)
FDA Unclassified
·Unknown
ROUND BUR, HIGH SPEED
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·October 3, 2014
BIOSURE
FDA Adverse Event
Malfunction
·MANSFIELD MANUFACTURING SITE·Product code HWC·June 3, 2013
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 27, 2011
ARCH KOH-EFFICIENT
FDA Adverse Event
Malfunction
·COOERSURGICAL INC.·Product code LKF·August 8, 2014
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·May 29, 2019
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA Staff, Replacement Reagent and Instrument Family Policy . DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
FDA Enforcement
Class I
·Terminated·Beckman Coulter Inc.·May 29, 2019
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·July 30, 2018
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA Staff, Replacement Reagent and Instrument Family Policy . DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·July 30, 2018