22 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503089·Leksell MPS Arc w Counter Scale - COUNTER SCALE...
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CADD
FDA UDI
ICU MEDICAL, INC.·15019517101010·
CADD
FDA UDI
ICU MEDICAL, INC.·15019517101034·
ADVIA CENTAUR XPT CEA
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DHX·May 30, 2019
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FRN·October 23, 2025
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014
PRODIGY LG STAT LNG RT 15.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·April 8, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 5, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·May 8, 2008
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L, 21-2111-0402-08, 21-2111-0402-08L, 21-2111-0402-09_LOAN, 21-2111-0402-09-FUK, 21-2111-0402-09JP, 21-2111-0402-09-KYO, 21-2111-0402-09-NAG, 21-2111-0402-09-OKA, 21-2111-0402-09-OSA, 21-2111-0402-09-SAP, 21-2111-0402-09-SEN, 21-2111-0402-09-TOKE, 21-2111-0402-09-TOKW, 21-2111-0402-09-YOK, 21-2111-0402-12L, 21-2111-0402-14L, 21-2111-0402-17L, 21-2111-0402-249, 21-2111-0402-51, 21-2111-0402-51L, 21-2111-0402-78, 21-2112-0100-50, 21-2112-0100-51, 21-2112-0200-02, 21-2112-0200-06, 21-2112-0300-00, 21-2112-0300-01, 21-2112-0300-02, 21-2112-0300-03, 21-2112-0300-06, 21-2112-0300-231, 21-2112-0300-50, 21-2112-0400-01, 21-2112-0400-51, 21-2112-0401-02L, 21-2112-0401-03L, 21-2112-0401-07L, 21-2112-0401-08L, 21-2112-0401-17L, 21-2112-0401-51, 21-2112-0401-51L, 21-2112-0401-78, 21-2112-0402-02, 21-2112-0402-02L, 21-2112-0402-03L, 21-2112-0402-06L, 21-2112-0402-07L, 21-2112-0402-08L, 21-2112-0402-09JP, 21-2112-0402-09-SAI, 21-2112-0402-09-SEN, 21-2112-0402-09-TOKE, 21-2112-0402-17L, 21-2112-0402-249, 21-2112-0402-51, 21-2112-0402-51L, 21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-06, 21-2120-0100-232, 21-2120-0100-233, 21-2120-0100-50, 21-2120-0100-51, 21-2120-0100-95, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-07, 21-2120-0102-08, 21-2120-0102-12, 21-2120-0102-13, 21-2120-0102-14, 21-2120-0102-15, 21-2120-0102-17, 21-2120-0102-247, 21-2120-0102-249, 21-2120-0102-51, 21-2120-0102-78, 21-2120-0102-92, 21-2120-0102-98, 21-2120-0103-01, 21-2120-0103-02, 21-2120-0103-03, 21-2120-0103-06, 21-2120-0103-07, 21-2120-0103-08, 21-2120-0103-14, 21-2120-0103-15, 21-2120-0103-17, 21-2120-0103-249, 21-2120-0103-51, 21-2120-0103-78, 21-2120-0104-01, 21-2120-0105-00, 21-2120-0105-01, 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-231, 21-2120-0105-50, 21-2120-0105-50L, 21-2125-0104-01, 21-2125-0105-07L, 21-2125-0105-08L, 21-2125-0105-50L, 21-2127-0104-01, 21-2127-0105-01, 21-2127-0105-02L, 21-2127-0105-03L, 21-2127-0105-06L, 21-2127-0105-08L, 21-2127-0105-50L, 22-4095-0203-51, 22-4095-0204-25, 22-4095-0205-25.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·November 6, 2024
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L, 21-2111-0402-08, 21-2111-0402-08L, 21-2111-0402-09_LOAN, 21-2111-0402-09-FUK, 21-2111-0402-09JP, 21-2111-0402-09-KYO, 21-2111-0402-09-NAG, 21-2111-0402-09-OKA, 21-2111-0402-09-OSA, 21-2111-0402-09-SAP, 21-2111-0402-09-SEN, 21-2111-0402-09-TOKE, 21-2111-0402-09-TOKW, 21-2111-0402-09-YOK, 21-2111-0402-12L, 21-2111-0402-14L, 21-2111-0402-17L, 21-2111-0402-249, 21-2111-0402-51, 21-2111-0402-51L, 21-2111-0402-78, 21-2112-0100-50, 21-2112-0100-51, 21-2112-0200-02, 21-2112-0200-06, 21-2112-0300-00, 21-2112-0300-01, 21-2112-0300-02, 21-2112-0300-03, 21-2112-0300-06, 21-2112-0300-231, 21-2112-0300-50, 21-2112-0400-01, 21-2112-0400-51, 21-2112-0401-02L, 21-2112-0401-03L, 21-2112-0401-07L, 21-2112-0401-08L, 21-2112-0401-17L, 21-2112-0401-51, 21-2112-0401-51L, 21-2112-0401-78, 21-2112-0402-02, 21-2112-0402-02L, 21-2112-0402-03L, 21-2112-0402-06L, 21-2112-0402-07L, 21-2112-0402-08L, 21-2112-0402-09JP, 21-2112-0402-09-SAI, 21-2112-0402-09-SEN, 21-2112-0402-09-TOKE, 21-2112-0402-17L, 21-2112-0402-249, 21-2112-0402-51, 21-2112-0402-51L, 21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-06, 21-2120-0100-232, 21-2120-0100-233, 21-2120-0100-50, 21-2120-0100-51, 21-2120-0100-95, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-07, 21-2120-0102-08, 21-2120-0102-12, 21-2120-0102-13, 21-2120-0102-14, 21-2120-0102-15, 21-2120-0102-17, 21-2120-0102-247, 21-2120-0102-249, 21-2120-0102-51, 21-2120-0102-78, 21-2120-0102-92, 21-2120-0102-98, 21-2120-0103-01, 21-2120-0103-02, 21-2120-0103-03, 21-2120-0103-06, 21-2120-0103-07, 21-2120-0103-08, 21-2120-0103-14, 21-2120-0103-15, 21-2120-0103-17, 21-2120-0103-249, 21-2120-0103-51, 21-2120-0103-78, 21-2120-0104-01, 21-2120-0105-00, 21-2120-0105-01, 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-231, 21-2120-0105-50, 21-2120-0105-50L, 21-2125-0104-01, 21-2125-0105-07L, 21-2125-0105-08L, 21-2125-0105-50L, 21-2127-0104-01, 21-2127-0105-01, 21-2127-0105-02L, 21-2127-0105-03L, 21-2127-0105-06L, 21-2127-0105-08L, 21-2127-0105-50L, 22-4095-0203-51, 22-4095-0204-25, 22-4095-0205-25.
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FRN·July 16, 2024
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA 21-2111-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA ¿ 21-2112-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA ¿ 21-2111-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA 21-2112-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0402-51 PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA ¿ 21-2111-0100-51 PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA ¿ 21-2112-0100-51
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024