BEUDAMED
    28 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    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

    FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    DAL-RO Threaded Female Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    DAL-RO Housing, Female Assembly Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    DAL-RO Abutment Dental implants

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

    VER2 DBL OFFSET RASP HANDLE, LT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    Vl DBL OFFST WI LRG STPL, RT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 2-8-526 ASSY, HOOKUP FUJI 4K+JET 2-8-527 ASSY, FUJI 700 NO FWJ 2-8-528 HOOK, EI-580BT 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 2-8-537 ASSY, HKUP, PTX90 4K+JET 2-8-539 HOOK, PTX I20 FWJ 2-8-540 ASSY-HOOK-UP,STORZ,5K 2-8-611 ASSY, HOOK-UP, OLY 2-8-612 ASSY, HOOKUP, PENTAX 2-8-614 ASM HU OLY TGF-UC180J 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 2-8-625 ASSY, HOOKUP, EG-580UT 2-8-626 ASSY, HOOKUP, EG-580UR 2-8-627 ASSY, HKUP, FUJI 700 SER 2-8-634 ASSY, HOOKUP PENTAX DUAL 2-8-639 HOOK, EG3X-J10 2-8-640 ASSY,HOOK-UP STORZ 6K 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 2-8-718 ASSY, HOOKUP, OLY 160/180 2-8-740 ASSY, HOOK-UP, STORZ 2-8-811 ASSY HKUP OLY-ECHO+LIFT 2-8-901 KIT TEE/TOE/RUS HU ADV+ 5-8-010 ASSY, HOOKUP DBL LT 5-8-030 ASSY, HOOKUP 5-8-040 ASSY HOOKUP STORZ 0K DBL 5-8-050 ASSY, HOOKUP, DILATOR 5-8-112 HOOKUP 2-SCOPE 1-K 5-8-190 HOOK DBL, IS, ION 5-8-210 ASSY, HOOKUP 5-8-245 HOOKUP KARLSTORZ-2K 2-8-001HAN HU ZERO CHANNEL NO LT 2-8-002HAN ADVANTAGE TEST BLOCK 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 2-8-160HAN ASSY, ADV HOOKUP, WOLF 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 2-8-218HAN ASSY HOOKUP OLY 2K 2-8-245HAN ASSY, HOOKUP, STORZ-2K 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 2-8-335HAN ASSY,HOOKUP,OLYMPUS 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 2-8-421HAN ASSY, HOOKUP, FUJINON 2-8-428CAS HOOK, CAS, ED-580XX 2-8-428HAN HOOK, HAN, ED-580XX 2-8-431CAS ASSY, CASSETTE, PENTAX 2-8-431HAN ASSY, HOOK-UP, PENTAX 2-8-511HAN ASSY, HOOK-UP, OLY 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 2-8-537HAN ASSY HKUP,PTX90 4K+JET 2-8-611HAN ASSY, HOOK-UP, OLY 2-8-626CAS ASSY, CASS, FUJINON 580UR 2-8-627HAN ASSY, HAN, FUJI 700 SER 2-8-634CAS ASSY,CASS PENTAX DUAL CH 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 2-8-640HAN ASSY, HOOK-UP STORZ 6K 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 2-8-902H HU BLOCK ULTRASOUND PROBE 5-8-030HAN ASSY, HOOKUP 5-8-050HAN ASSY,HOOKUP, DILATOR 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 5-8-244HAN ASSY, HKUP 2K DBL

    FDA Enforcement
    Class II ·Ongoing·Steris Corporation·January 3, 2024

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·September 10, 2014

    Normed Charcot Osteotome Chisel (Various sizes)

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·April 18, 2018

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·September 26, 2018

    VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Enforcement
    Class II ·Terminated·Del Medical, Inc.·February 17, 2016

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Enforcement
    Class II ·Terminated·Del Medical, Inc.·February 17, 2016

    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·February 18, 2015

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·July 31, 2013