61 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Enforcement
Class II
·Ongoing·Ossur H / F·May 22, 2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
FDA Enforcement
Class II
·Ongoing·Ossur H / F·January 31, 2024
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
FDA Enforcement
Class II
·Ongoing·Ossur H / F·June 21, 2023
MiniMed 720G Insulin Pump (O.U.S. Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
FDA Enforcement
Class II
·Ongoing·HF Acquisition Co LLC·June 17, 2026
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave¿ sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
FDA Enforcement
Class II
·Ongoing·HF Acquisition Co LLC·June 17, 2026
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
FDA Enforcement
Class II
·Ongoing·HF Acquisition Co LLC·February 19, 2025
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)
FDA Enforcement
Class II
·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·October 23, 2019
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS;¿ PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1742KX 670G V6.1 MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿
FDA Enforcement
Class II
·Ongoing·Medtronic Minimed·June 9, 2021
MiniMed 620G Insulin Pump (O.U.S. version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X
FDA Enforcement
Class II
·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·October 23, 2019
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
MiniMed 630G Insulin Pump (U.S. and Canada Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
MiniMed 780G Insulin Pump (O.U.S. Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-1886XC 780G V6.5 CLIN MG;¿ PUMP MMT-1885L MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886L MM780G 6.5W BLE MG;¿ KIT MMT-1896ES MM780G V6.5W MG;¿ KIT MMT-1896WWA MM780G BLE MG ES;¿ KIT MMT-1895WWA MM780G BLE MMOL AR;¿ KIT MMT-1895WWA MM780G BLE MMOL CS;¿ KIT MMT-1895WWA MM780G BLE MMOL DA;¿ KIT MMT-1895WWA MM780G BLE MMOL DE;¿ KIT MMT-1895WWA MM780G BLE MMOL EN;¿ KIT MMT-1895WWA MM780G BLE MMOL FI;¿ KIT MMT-1895WWA MM780G BLE MMOL FR;¿ KIT MMT-1895WWA MM780G BLE MMOL IT;¿ KIT MMT-1895WWA MM780G BLE MMOL NL;¿ KIT MMT-1895WWA MM780G BLE MMOL NO;¿ KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV;¿ KIT MMT-1895WWA MM780G BLE MMOL HU;¿ KIT MMT-1896WWA MM780G BLE MG AR;¿ KIT MMT-1896WWA MM780G BLE MG DE;¿ KIT MMT-1896WWA MM780G BLE MG EL;¿ KIT MMT-1896WWA MM780G BLE MG HE;¿ KIT MMT-1896WWA MM780G BLE MG IT;¿ KIT MMT-1896WWA MM780G BLE MG PL;¿ KIT MMT-1896WWA MM780G BLE MG RO;¿ KIT MMT-1896WWA MM780G BLE MG TR;¿ KIT MMT-1896WWA MM780G BLE MG NL;¿ KIT MMT-1896WWA MM780G BLE MG FR;¿ KIT MMT-1896WWA MM780G BLE MG ES;
FDA Enforcement
Class II
·Ongoing·Medtronic Minimed·June 9, 2021
MiniMed 640G Insulin Pump (O.U.S. Version)
FDA Enforcement
Class II
·Ongoing·Medtronic MiniMed·July 20, 2022