15 results
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11ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
FDA Enforcement
Class II
·Terminated·Gi Supply·March 16, 2016
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·Medivators, Inc.·April 29, 2020
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·Medivators, Inc.·April 29, 2020
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
Optima CT 540
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Optima CT 520
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
CT Goldseal Optima CT 600
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Revolution CT 160 1.5D STD WAUK
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Discovery MI Digital Ready
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Discovery RT labeled as: a. MID BJG; b. HVY BJG
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·July 2, 2025