BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.

    FDA Enforcement
    Class II ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 1, 2020

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·December 23, 2020

    Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBI

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology Inc·November 7, 2012