BEUDAMED
    10,000 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·April 20, 2016

    Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o. C-SECTION PACK-LF p. C-SECTION PACK-LF q. C-SECTION PACK-LF r. C-BIRTH PACK-LF s. C SECTION PACK-LF t. C-SECTION PACK-LF u. C SECTION PACK-LF v. C-SECTION PACK-LF w. C SECTION PACK-LF x. C-SECTION PACK-LF y. C-SECTION PACK z. C-SECTION PACK-LF aa. C-SECTION PACK-LF bb. C-SECTION PACK-LF cc. C-SECTION PACK-LF dd. C-BIRTH SETUP PACK-LF ee. C-SECTION PACK-LF ff. C-SECTION PACK-LF gg. C-SECTION PACK-LF hh. C SECTION PACK-LF ii. C-SECTION PACK-LF jj. C-SECTION TRAY kk. C-SECTION PACK ll. C-SECTION PACK-LF mm. C-SECTION PACK nn. C-SECTION PACK oo. C-SECTION pp. C-SECTION PACK qq. SVMMC C-SECTION PACK rr. C-SECTION PACK-LF ss. C-SECTION SETUP PACK tt. C-SECTION PACK uu. C-SECTION PACK vv. C-SECTION PACK *STANDARD* ww. C-SECTION PACK xx. C-SECTION PACK yy. C-SECTION PACK zz. C-SECTION 83305, MERCY REG aaa. CUH C-SECTION PACK-LF bbb. C-SECTION PACK-LF ccc. C-SECTION PACK ddd. C-SECTION PACK eee. C-SECTION PACK fff. C-SECTION PK ggg. C-SECTION hhh. C-SECTION PACK iii. ST JO WEST C-SECTION BASIN-LF jjj. C SECTION PACK kkk. C-SECTION PACK lll. C SECTION PACK mmm. C SECTION DELIVERY nnn. C-SECTION PACK ooo. C-SECTION PACK ppp. C SECTION qqq. WR C SECTION PACK-LF rrr. C-SECTION PACK sss. PK, L&D-C SECTION ttt. C-SECTION PACK HIGHLAND-LF uuu. C- SECTION vvv. C SECTION PACK-LF www. C-SECTION PACK xxx. C-SECTION PACK yyy. C SECTION PACK zzz. PK, L&D-C SECTION aaaa. C SECTION PACK bbbb. C SECTION PACK cccc. C-SECTION PACK dddd. SECTION PACK (CSSJE)642-LF eeee. C-SECTION PACK ffff. C-SECTION PACK-RFD gggg. C-SECTION DELIVERY PACK-LF hhhh. C-SECTION PACK iiii. C SECTION PACK jjjj. C-SECTION PACK kkkk. C SECTION llll. C SECTION PLUS PACK mmmm. C SECTION PACK-6220 nnnn. C-SECTION PACK oooo. C-SECTION PACK pppp. C-SECTION PACK - WCH qqqq. C SECTION WITH BASIN PACK rrrr. PHP C-SECTION PACK-LF ssss. C-SECTION KIT tttt. C SECTION PACK uuuu. C-SECTION vvvv. C-SECTION I PACK-LF wwww. C-SECTION PACK 2 xxxx. C-SECTION PACK-LF yyyy. C-SECTION PACK zzzz. C-SECTION PACK aaaaa. C SECTION PACK bbbbb. C-SECTION PACK ccccc. C SECTION ddddd. C SECTION PACK-LF eeeee. C SECTION PACK-LF fffff. BSMI CSECTION BIRTHING PACK ggggg. C-SECTION PACK hhhhh. C SECTION PACK-LF iiiii. C-SECTION PACK jjjjj. C SECTION PACK kkkkk. C SECTION lllll. PK, L&D-C SECTION mmmmm. C-SECTION PACK nnnnn. C SECTION ooooo. C-SECTION PACK ppppp. C-SECTION SMMC qqqqq. C SECTION PACK rrrrr. C SECTION PACK sssss. C-SECTION PACK ttttt. C SECTION #2 SHARED uuuuu. C SECTION #3 SHARED vvvvv. C SECTION wwwww. C-SECTION PACK xxxxx. CESAREAN BIRTH PACK yyyyy. C SECTION PACK-LF zzzzz. C-SECTION PACK aaaaaa. C-SECTION PACK-LF bbbbbb. C SECTION PACK cccccc. C-SECTION PACK dddddd. C-SECTION eeeeee. C-SECTION ffffff. C SECTION gggggg. C-SECTION hhhhhh. C SECTION iiiiii. C-SECTION jjjjjj. C-SECTION kkkkkk. PROHEALTH C-SECTION llllll. C SECTION mmmmmm. C SECTION nnnnnn. C-SECTION oooooo. C-SECTION pppppp. C-SECTION PACK qqqqqq. C SECTION rrrrrr. C SECTION ssssss. C-SECTION tttttt. C SECTION uuuuuu. C-SECTION - SMH vvvvvv. C-SECTION MRMC wwwwww. SCHED C SECTION xxxxxx. C-SECTION yyyyyy. C-SECTION -LF zzzzzz. ADVENTIST C-SECTION PACK aaaaaaa. C-SECTION PK-LF bbbbbbb. C-SECTION PROCEDURE ccccccc. C-SECTION II-LF ddddddd. C-SECTION I-LF eeeeeee. C-SECTION PACK fffffff. C-BIRTH PACK-LF ggggggg. C-SECTION PACK hhhhhhh. THEDACARE C-SECTION iiiiiii. C-SECTION BASIN PACK jjjjjjj. C-SECTION PACK kkkkkkk. C-SECTION PACK-LF lllllll. PPH C-SECTION PACK-LF mmmmmmm. C SECTION PACK-LF nnnnnnn. C-SECTION PACK ooooooo. C-SECTION PACK-LF

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    FDA Enforcement
    Class II ·Terminated·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·June 1, 2016

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019

    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·October 17, 2018

    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·April 25, 2018

    Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.

    FDA Enforcement
    Class II ·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013

    Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25" Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2" x 2.25" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.

    FDA Enforcement
    Class II ·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013

    Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2" x 3.5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3" x 5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2" x 4" Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.

    FDA Enforcement
    Class II ·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013

    Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.

    FDA Enforcement
    Class II ·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013

    Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016

    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016