10,000 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
BD Pyxis Product Name / UDI-DI code / Catalog No. 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 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System 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, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·September 3, 2025
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·June 5, 2024
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Enforcement
Class II
·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Enforcement
Class II
·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Enforcement
Class II
·Ongoing·Hitachi America, Ltd., Particle Therapy Division·September 18, 2024
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·April 9, 2025
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
FDA Enforcement
Class II
·Ongoing·O&M HALYARD, INC.·January 29, 2025
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·June 5, 2024