BEUDAMED
    416 results · 13ms · 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 FDA Recall × Status: Open, Classified × Clear all

    MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFC·March 11, 2026

    Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFC·March 11, 2026

    Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFC·April 21, 2026

    Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

    FDA Recall
    Open, Classified ·MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands·Product code BXB·July 29, 2019

    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Recall
    Open, Classified ·Hologic Inc·Product code OTE·August 19, 2024

    Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 4, 2023

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

    FDA Recall
    Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

    FDA Recall
    Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024

    ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

    FDA Recall
    Open, Classified ·Welch Allyn Inc Mortara·Product code DPS·September 3, 2021

    OEC Elite Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    OEC Flexiview 8800 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    OEC 9900 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023

    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025