BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    INVUITY(R) PhotonBlade(TM), REF PB1

    FDA Enforcement
    Class II ·Terminated·Invuity, Inc.·August 2, 2017

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Enforcement
    Class II ·Terminated·Medtronic·December 28, 2016

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017

    GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p) D670 DR 3/8 inch MEA, q) D670 DR 3/8 inch, r) D670 DR 3/8 inch 16SL, s) D670 DR 3/8 inch 16SL NR, t) D670 DR 3/8 inch BJ, u) D670 DR 3/8 inch MEA, v) D670 DR NM Gantry 3/8 inch, w) D670 DR NM Gantry 5/8 inch, x) D670 DR with new rotor, y) D670 ES NM Gantry 3/8 inch, z) D670 ES NM/CT 3/8 inch O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8 inch, bb) D670 GANTRY, cc) D670 PRO NM Gantry 3/8 inch, dd) D670 PRO NM GANTRY 3/8 inch, ee) DISC NM/CT670 DR 3/8 inch, ff) DISC NM/CT870 DR 3/8 inch, gg) DISC NM/CT870 DR 3/8 inch, hh) DISC NM/CT870 DR 5/8 inch, ii) DISCOVERY 670 (TANDEM), jj) DISCOVERY NM 670, kk) DISCOVERY NM/CT 670 3/8 inch PRO, ll) DISCOVERY NM/CT 670 3/8 inch PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, nn) NM/CT 870 DR, oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE, pp) NM/CT 870 DR 3/8 inch WSO, qq) NM/CT 870 DR O540 3/8 inch, rr) NM/CT 870 DR O540 3/8 inch BJ, ss) NM/CT 870 DR O540 5/8 inch, tt) NM/CT 870 ES 3/8 inch, uu) NM/CT 870DR China for China, vv) NM/CT870 DR 3/8 inch O540, ww) NM/CT D870 DR O540 3/8 inch, xx) TANDEM DISCOVERY 670 INT; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026