BEUDAMED
    22 results · 18ms · Sources: EU EUDAMED, US FDA

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

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 18, 2017

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·February 15, 2017

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·July 9, 2014

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·September 26, 2018

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    AXIOM Artis dFC, Model Number 7727717

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    AXIOM Artis dFC, Model Number 7412807

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·January 24, 2024

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·September 4, 2013

    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·March 21, 2018

    ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

    FDA Enforcement
    Class II ·Ongoing·Welch Allyn Inc Mortara·October 13, 2021

    Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.

    FDA Enforcement
    Class II ·Terminated·Steritec Products Mfc. Co., Inc.·August 7, 2013

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·March 21, 2018