38 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
FDA Enforcement
Class II
·Terminated·CareFusion Corporation·April 3, 2013
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 19, 2025
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·October 6, 2021
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 19, 2025
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·October 6, 2021
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 6, 2019
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·October 17, 2018
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 16, 2023
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·March 29, 2023
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Enforcement
Class II
·Terminated·Vitrolife Inc·April 22, 2015
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF CR 13MM PLY R 3-9 42521000613 PSN ASF CR 13MM PLY R 7-1 42511000514 PSN ASF CR 14MM PLY L 3-1 42511000414 PSN ASF CR 14MM PLY L 3-9 42511000614 PSN ASF CR 14MM PLY L 7-1 42521000514 PSN ASF CR 14MM PLY R 3-1 42521000414 PSN ASF CR 14MM PLY R 3-9 42521000614 PSN ASF CR 14MM PLY R 7-1 42511000516 PSN ASF CR 16MM PLY L 3-1 42511000416 PSN ASF CR 16MM PLY L 3-9 42511000616 PSN ASF CR 16MM PLY L 7-1 42521000516 PSN ASF CR 16MM PLY R 3-1 42521000416 PSN ASF CR 16MM PLY R 3-9 42521000616 PSN ASF CR 16MM PLY R 7-1 42511000518 PSN ASF CR 18MM PLY L 3-1 42511000418 PSN ASF CR 18MM PLY L 3-9 42511000618 PSN ASF CR 18MM PLY L 7-1 42521000518 PSN ASF CR 18MM PLY R 3-1 42521000418 PSN ASF CR 18MM PLY R 3-9 42521000618 PSN ASF CR 18MM PLY R 7-1 42511400810 PSN ASF PS 10MM PLY L 10- 42511401010 PSN ASF PS 10MM PLY L 10- 42511400410 PSN ASF PS 10MM PLY L 3-5 42511400610 PSN ASF PS 10MM PLY L 3-5 42511400510 PSN ASF PS 10MM PLY L 6-9 42511400710 PSN ASF PS 10MM PLY L 6-9 42511400910 PSN ASF PS 10MM PLY L 6-9 42521400810 PSN ASF PS 10MM PLY R 10- 42521401010 PSN ASF PS 10MM PLY R 10- 42521400410 PSN ASF PS 10MM PLY R 3-5 42521400610 PSN ASF PS 10MM PLY R 3-5 42521400510 PSN ASF PS 10MM PLY R 6-9 42521400710 PSN ASF PS 10MM PLY R 6-9 42521400910 PSN ASF PS 10MM PLY R 6-9 42511400811 PSN ASF PS 11MM PLY L 10- 42511401011 PSN ASF PS 11MM PLY L 10- 42511400411 PSN ASF PS 11MM PLY L 3-5 42511400611 PSN ASF PS 11MM PLY L 3-5 42511400511 PSN ASF PS 11MM PLY L 6-9 42511400711 PSN ASF PS 11MM PLY L 6-9 42511400911 PSN ASF PS 11MM PLY L 6-9 42521400811 PSN ASF PS 11MM PLY R 10- 42521401011 PSN ASF PS 11MM PLY R 10- 42521400411 PSN ASF PS 11MM PLY R 3-5 42521400611 PSN ASF PS 11MM PLY R 3-5 42521400511 PSN ASF PS 11MM PLY R 6-9 42521400711 PSN ASF PS 11MM PLY R 6-9 42521400911 PSN ASF PS 11MM PLY R 6-9 42511400812 PSN ASF PS 12MM PLY L 10- 42511401012 PSN ASF PS 12MM PLY L 10- 42511400412 PSN ASF PS 12MM PLY L 3-5 42511400612 PSN ASF PS 12MM PLY L 3-5 42511400512 PSN ASF PS 12MM PLY L 6-9 42511400712 PSN ASF PS 12MM PLY L 6-9 42511400912 PSN ASF PS 12MM PLY L 6-9 42521400812 PSN ASF PS 12MM PLY R 10- 42521401012 PSN ASF PS 12MM PLY R 10- 42521400412 PSN ASF PS 12MM PLY R 3-5 42521400612 PSN ASF PS 12MM PLY R 3-5 42521400512 PSN ASF PS 12MM PLY R 6-9 42521400712 PSN ASF PS 12MM PLY R 6-9 42521400912 PSN ASF PS 12MM PLY R 6-9 42511400813 PSN ASF PS 13MM PLY L 10- 42511401013 PSN ASF PS 13MM PLY L 10- 42511400413 PSN ASF PS 13MM PLY L 3-5 42511400613 PSN ASF PS 13MM PLY L 3-5 42511400513 PSN ASF PS 13MM PLY L 6-9 42511400713 PSN ASF PS 13MM PLY L 6-9 42511400913 PSN ASF PS 13MM PLY L 6-9 42521400813 PSN ASF PS 13MM PLY R 10- 42521401013 PSN ASF PS 13MM PLY R 10- 42521400413 PSN ASF PS 13MM PLY R 3-5 42521400613 P
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
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
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
FDA Enforcement
Class II
·Terminated·Owen Mumford USA, Inc.·July 22, 2015
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
FDA Enforcement
Class II
·Terminated·Medtronic Advanced Energy, LLC·February 12, 2014