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SMITH & NEPHEW CDS SYSTEM
 Request for Information Form |
 Contact Information
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| Company Name | ACCELLENT INC. |
| Address | 1526-6 CALLE HERTZ |
| City, State, Zip | JUAREZ, CHIHUAHUA, |
| Country | MX |
| FDA Owner/Operator Phone | 866-899-1392 |
| FDA Medical Specialty Code | RA - Radiology |
| FDA Product Code | JAA |
| FDA Classification Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 892.1650 |
| FDA Common Generic Name | DISPOSABLE SET, CDS |
| FDA Proprietary Device Name | SMITH & NEPHEW CDS SYSTEM |
| FDA Owner / Operator Number | 9048369 |
| FDA Owner / Operator Name | ACCELLENT INC. |
| FDA Establishment Registration Number | 9680001 |
| FDA Registered Establishment Name | ACCELLENT INC. |
| FDA Operation Code(s) |
ME - Contract Manufacturer MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 09-21-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ACCELLENT INC.
Our records indicate that the following medical device companies may manufacture a similar device.| Company Name / Address / Phone | Proprietary Device Name | Common Generic Device Name | |
| 1 | ABSOLUTE X-RAY IMAGING 205 NORTH LITTLE TOR RD. NEW CITY, NY 10956 US 914-638-8080 / 914-638-8080 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 2 | AFP IMAGING CORP. 250 CLEARBROOK RD. ELMSFORD, NY 10523 US 914-592-6100 / 914-592-6100 |
MTT-90 REMOTE CONTROLLED R/F SYSTEM | REMOTE CONTROL FLUOROSCOPY SYSTEM |
| 3 | ANEXA CORPORATION 8 CENTENNIAL DR. PEABODY, MA 01960 US 978-326-4000 / 978-326-4619 |
ANEXA ORBIS C AND ANEXA ORBIS ED | MOBILE FLUOROSCOPIC X-RAY SYSTEMS |
| 4 | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US 508-652-5594 / 508-652-5594 |
MAP | DC-COUPLED, ISOLATED PREAMPLIFIER |
| 5 | BRAND X-RAY CO., INC. 910 WESTWOOD AVE. ADDISON, IL 60101 US 630-543-5331 / 630-543-5331 |
TUBE, X-RAY | |
| 6 | CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042 US 81-3-3758 2111 / 516-328-5602 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 7 | COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE GEORGETOWN,ONTARIO, L7G 2J4 CA 905-877-0161 / 905-877-0161 |
CPIVISION DIGITAL IMAGING SYSTEM | DIGITAL IMAGING SYSTEM |
| 8 | DIREX SYSTEMS CORP. 437 TURNPIKE ST. CANTON, MA 02021 US 339-502-6013 / 888-874-7837 |
VERT-X | VARIOUS TYPES OF FLUOROSCOPIC X-RAY SYSTEMS |
| 9 | DMX-WORKS, INC. 4159-B CORPORATE COURT PALM HARBOR, FL 34683 US 800-839-6757 / 800-839-6757 |
DIGITAL MOTION X-RAY SYSTEM | VARIOUS MODELS OF DIGITAL MOTION X-RAY SYSTEMS |
| 10 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.1, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE BEIJING PR, 100176 CH 847-277-5002 / 262-544-3894 |
MULTIPLE | TYPES OF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS |
| 11 | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 847-277-5002 / 262-544-3894 |
POLARIX | MOBILE IMAGE INTENSIFIER UNIT |
| 12 | GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. SALT LAKE CITY, UT 84116 US 847-277-5002 / 801-517-6440 |
MULTIPLE | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| 13 | GE OEC MEDICAL SYSTEMS GMBH 14 WILHELM-MAISEL-STR. WENDELSTEIN, D-90530 GM 847-277-5002 / 801-536-4977 |
OEC 7700, SERIES, COMPACT & COMPACT PLUS/FLUOROSTAR/7600,COMPACT/7600, SERIES | MOBILE C-ARM |
| 14 | GENERAL MEDICAL MERATE S.P.A. VIA PARTIGIANI, 25 SERIATE, BERGAMO, 24068 IT / 720-962-5412 |
MULTIPLE | VARIOUS MODELS OF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEMS |
| 15 | HAMAMATSU PHOTONICS, K.K. 325-6 SUNAYAMA-CHO HAMAMATSU CITY, 430 JA 81-534-52-2141 / 908-231-0960 2300 |
NO PROPRIETARY NAME LISTED | X-RAY IMAGE INTENSIFIER |
| 16 | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 US 781-999-7300 / 781-999-7368 |
FLUORO SCAN IMAGING SYSTEM | FLUOROSCOPE |
| 17 | IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. STERLING, MA 01564 US 978-422-8601 / 978-422-8601 |
ID400 SERIES ARMBOARDS | ARBOARDS |
| 18 | INFIMED, INC. 121 METROPOLITAN DR. LIVERPOOL, NY 13088 US 315-453-4545 / 315-453-4545 323 |
ORION DIGITAL IMAGING SYSTEM | X-RAY SYSTEM |
| 19 | INTEGRATED TECHNOLOGIES OF SOUTHWEST FLORIDA, INC. 3800 FOWLER ST., UNIT 1 FORT MYERS, FL 33901 US 239-275-4888 / 239-275-4888 |
MULTIPLE | VARIOUS |
| 20 | INTEGRITY PRACTICE MANAGEMENT, INC. 7501 E HIGHWAY 42 SIOUX FALLS, SD 57110 US / 605-728-1976 |
VARIOUS MODELS OF C-ARMS | C-ARM |
| 21 | LAKESHORE TECHNOLOGIES INC. 7536 MURRAY DR. CICERO, NY 13039 US 315-699-2975 / 315-699-2975 |
FLUORECORD MODEL 762 | DIGITAL SPOT SYSTEM |
| 22 | LIFECARE IMAGING INTL., LTD. 8411 PYOTT RD. LAKE IN THE HILLS, IL 60102 US 815-477-1291 / 815-477-1291 |
V7SS IMAGER | MOBILEFLUOROSCOPIC C-ARM |
| 23 | LIXI, INC. 11980 OAK CREEK PARKWAY HUNTLEY, IL 60142 US 847-961-6666 225 / 847-961-6666 225 |
LIXISCOPE | VARIOUS MODELS OF LIXISCOPE |
| 24 | MEDICAL TECHNIQUES, INC. 125 NORTH 400 WEST, STE, C NORTH SALT LAKE, UT 84054 US / 801-936-4501 |
ARTHROGRAM TRAY | ARTHROGRAM TRAY/KIT/PACK |
| 25 | MEDISONXRAY CO., LTD. 251-30, MOKDONG-RI, GYOHA-EUP PAJU, GYEONGGI-DO, 413-833 KS 82-2-21943221 / 82-2-21943221 |
MCA-6100 MOBILE C-ARM | MCA-6100 MOBILE C-ARM |
| 26 | MINRAD, INC. 50 COBHAM DR. ORCHARD PARK, NY 14127 US 716-855-1068 / 716-855-1068 |
DRTS | REMOTE CONTROL DRAPE |
| 27 | NICAL SPA 43 VIA SOFFREDINI MILAN (MI), 20126 IT 39-02-2571110 / 914-275-7679 |
MULTIPLE MODELS | FLUOROSCOPIC IMAGING SYSTEMS |
| 28 | NRT-NORDISK RONTGEN TEKNIK A/S BIRKEGAARDSVEJ 16 HASSELAGER, 8361 DA 458-628-3500 / 720-962-5412 |
MULTIPLE | VARIOUS MODELS OF IMAGE0INTESIFIED FLOUROSCOPIC X-RAY SYSTEMS |
| 29 | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE SANFORD, FL 32771 US 407-323-9400 / 407-323-9400 |
E-VIEW FLUOROSCOPY SYSTEM | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIED |
| 30 | PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. 1 ORG SANAYI BOLGES ORHAN ISIK CAD 4 SINCAN ANKARA, 06935 TU 90-312-2672046 / 90-312-2672046 |
UROVANTAGE/MULTIVANTAGE | UROLOGICAL TABLE |
| 31 | PERKINS ELECTRONICS CO. 1510 N.WASHINGTON AVE. DALLAS, TX 75204 US 214-828-4545 / 214-828-4545 109 |
MULTIPLE | VIDEO CONTROLLER |
| 32 | PHILIPS MEDICAL SYSTEMS JAN CAMPERTSTRAAT 5 HEERLEN, 6416-SG NL 425-487-7000 / 978-659-4663 |
MULTIPLE | IMAGE INTENSIFIED FLUOROSCOPIC SYSTEMS, COMPONENTS PARTS AND ACCESSORIES |
| 33 | PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND ROENTGENSTRASSE 24 HAMBURG, D-22335 GM 425-487-7000 / 978-659-4663 |
MULTIPLE | IMAGE INTENSIFIED FLUOROSCOPIC SYSTEMS, COMPONENTS |
| 34 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 BEST, 5684 PC NL 425-487-7000 / 978-659-4663 |
MULTIPLE | FLUOROSCOPIC X-RAY SYSTEM |
| 35 | PRECISE OPTICS 239 SOUTH FEHR WAY BAY SHORE, NY 11706 US 631-242-6600 / 631-242-6600 |
FLUROSCOPIE X-RAY SYSTEM, AUTOMATIC BRIGHTNESS STABILIZER | FLUOROSCOPIC X-RAY SYSTEM, AUTOMATIC BRIGHTNESS STABILIZER |
| 36 | PREFERRED MEDICAL PRODUCTS 191 INDUSTRIAL DR. DUCKTOWN, TN 37326 US 423-496-3738 / 423-496-3738 |
EAZY COVERS | VARIOUS STERILE EQUIPMENT COVERS |
| 37 | QR S.R.L. VIA SILVESTRINI 20 VERONA, VR, 37135 IT 914-592-6100 / 39-045-8202727 |
NEWTOM 3G QR-DVT 9000 | COMPUTED TOMOGRAPHY X-RAY SYSTEM |
| 38 | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 FORCHHEIM, 91301 GM / 610-448-4153 |
MULTIPLE | IMAGE INTENSIFIED X-RAY SYSTEM |
| 39 | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 ERLANGEN, 91052 GM / 610-448-4153 |
MULTIPLE | IMAGE INTENSIFIED X-RAY SYSTEM |
| 40 | SIMAD MEDICAL TECHNOLOGY SRL VIA MARSALA 29 MIRANDOLA, MO, 41037 IT 011- 39-053524305 / 39-05-3524305 |
SIMAD MEDICAL TECHNOLOGY | MOBILE C-ARM |
| 41 | SMITH & NEPHEW INC., ENDOSCOPY DIV. 76 S. MERIDIAN AVE. OKLAHOMA CITY, OK 73107 US 978-749-1000 / 978-749-1073 |
SMITH & NEPHEW CDS DISCOGRAPHY SYSTEM | DISCOGRAPHY SYSTEM |
| 42 | STORZ MEDICAL AG LOHSTAMPFESTRASSE 8 TAGERWILEN, CH-8274 SZ 41-071-677 45 45 / 678-354-6229 8812 |
STORZ MEDICAL X-RAY SYSTEM XR-MX | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY C-ARM |
| 43 | STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124 |
SONY 3500 VHS VCR | VCR |
| 44 | SUINSA C/. PRIMAVERA, 39 PARQUE IND. LAS MOJAS TORREJON DE ARDOZ MADRID, 28850 SP 34-916-55 9500 / 847-374-8854 |
MULTIPLE | IMAGE INTENSIFIED X-RAY SYSTEM |
| 45 | TECHNIX S.P.A. VIA FERMI 26 GRASSOBBIO, BG, 24050 IT |
PROFILE | MOBILE C-ARM IMAGING SYSTEM |
| 46 | THALES ELECTRON DEVICES CORP. 2 BIS RUE LATECOERE VELIZY, 78941 FR 33-130-703500 / 973-812-9000 |
X-RAY IMAGE INTENSIFIER TUBE IN ALUMINUM HOUSING | VARIOUS MODELS OF X-RAY IMAGE INTENSIFIER TUBES |
| 47 | TIDI PRODUCTS, LLC 570 ENTERPRISE DR. NEENAH, WI 54956 US 920-751-4300 / 920-751-4380 |
DRAPE FOR IMAGE INTENSIFIER, FLUOROSCOPE | |
| 48 | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385, SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI, 324-8550 JA / 714-730-5000 7808 |
MULTIPLE | VARIOUS MODELS OF FLUOROSCOPIC SYSTEMS |
| 49 | VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 BUCCINASCO, 20090 IT 914-686-3600 / 847-288-7000 7948 |
MULTIPLE | FLUROSCOPIC X-RAY SYSTEM |
| 50 | WORLD TECHNOLOGIES, INC. 708-6 DIAMOND LAKE RD. MUNDELEIN, IL 60060 US 847-949-4948 / 847-949-4948 |
PATHFINDER | MOBILE C-ARM |
| 51 | XTEC, INC. 2090 WEST DOWELL RD. COLUMBIA CITY, IN 46725 US 219-244-5400 / 219-244-5400 |
REBUILD DENTAL X-RAY TUBE ASSEMBLIES | |
| 52 | ZIEHM IMAGING GMBH DONAUSTRASSE 31 NUERNBERG, BAVARIA, 90451 GM 49-911-2172219 / 49-911-2172219 |
ZIEHM 7000 / ZIEHM VISTA | MOBILE SURGICAL C-ARM |
| 53 | ZIEHM IMAGING, INC. 4181 LATHAM ST. RIVERSIDE, CA 92501 US 951-781-2020 / 951-781-2020 140 |
ZIEHM VARIO-3D,VISION R,VISION FD | DIGITAL MOBILE IMAGING SYSTEM |
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