BEUDAMED
    15 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

    FDA Enforcement
    Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939293052030 (Material Description Innova 5 x 200 x 130); b. H74939293052070 (Material Description Innova 5 x 200 x 75); c. H74939293062030 (Material Description Innova 6 x 200 x 130); d. H74939293062070 (Material Description Innova 6 x 200 x 75); e. H74939293072030 (Material Description Innova 7 x 200 x 130); f. H74939293072070 (Material Description Innova 7 x 200 x 75); g. H74939293082030 (Material Description Innova 8 x 200 x 130); h. H74939293082070 (Material Description Innova 8 x 200 x 75)

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 28, 2018

    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75); b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75); c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75); d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75); e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130); f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130); g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130); h. H74939181081830 (Material Description Innova-EU 8 x 180 x 130); i. H74939259051830 (Material Description Innova-China 5 x 180 x 130); j. H74939259061830 (Material Description Innova-China 6 x 180 x 130); k. H74939259071830 (Material Description Innova-China 7 x 180 x 130); l. H74939259081830 (Material Description Innova-China 8 x 180 x 130); m. H74939259081870 (Material Description Innova-China 8 x 180 x 75); n.H74939293051830 (Material Description Innova 5 x 180 x 130); o. H74939293051870 (Material Description Innova 5 x 180 x 75); p. H74939293061830 (Material Description Innova 6 x 180 x 130); q. H74939293061870 (Material Description Innova 6 x 180 x 75); r. H74939293071830 (Material Description Innova 7 x 180 x 130); s. H74939293071870 (Material Description Innova 7 x 180 x 75); t. H74939293081830 (Material Description Innova 8 x 180 x 130); u. H74939293081870 (Material Description Innova 8 x 180 x 75);

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 28, 2018

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA Inc·April 1, 2020

    MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

    FDA Enforcement
    Class II ·Ongoing·AtriCure, Inc.·February 7, 2024

    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

    FDA Enforcement
    Class II ·Ongoing·AtriCure, Inc.·February 7, 2024

    SOMATOM Force, System x-ray, tomography, computed

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Enforcement
    Class II ·Terminated·LMA North America Inc·July 25, 2012

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Enforcement
    Class II ·Terminated·Integra Burlington MA, Inc.·April 10, 2013

    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·December 25, 2019

    Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 23) LACERATION TRAY, Pack Number DYNDL1757; 24) MYELOGRAM TRAY, Pack Number DYNDH1531; 25) OB DELIVERY SET, Pack Number MNS3355; 26) OB DELIVERY TRAY, Pack Number MNS10875; 27) OB DELIVERY TRAY, Pack Number MNS5575; 28) OB DELIVERY TRAY, Pack Number MNS10875A; 29) PICU LINE TRAY, Pack Number DYNDC1960A; 30) PORT ACCESS KIT, Pack Number DYNDC2945; 31) PORT ACCESS TRAY, Pack Number EBSI1241; 32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A; 33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 34) SUTURING SET, Pack Number SUT9790; 35) SUTURING SET, Pack Number SUT4020; 36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A; 37) U.A.C. TRAY, Pack Number UVT125; 38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020; 40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024