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

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·January 21, 2026

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021