16 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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EXCIA TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925014329·TILT-TOP TORP PROSTHESIS 9 MM LENGTH PLASTI-PORE
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313282·STABILITY TRIAL HUMERAL CUP 135/145° Ø40 +15
Humeral Cup Stability
FDA UDI
FX SOLUTIONS·03701037314210·STABILITY TRIAL HUMERAL CUP CUSTOM MADE 135/145...
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
FDA 510(k)
FDA Class 2
·Cardiovascular
Single Action Biopsy Device
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333218585·Single Action Biopsy Device 14g (2.1mm) x 9cm
Coaxial SABD Biopsy Device
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333218127·Coaxial SABD Biopsy Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 3, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·June 27, 2011
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
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014