BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ECA MEDICAL INSTRUMENTS

    Reg #: 3010052483 · FEI: 3010052483 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    178
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    ECA MEDICAL INSTRUMENTS
    Registration Number
    3010052483
    FEI Number
    3010052483
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    ZIP
    91320
    Country
    US

    Owner / Operator

    Firm Name
    ECA Medical Instruments
    Operator Number
    10042970
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    Postal Code
    91320
    Country
    US
    Correspondent
    Janice Grace

    Products

    Device Name Product Code
    Instrument, Surgical, Non-Powered HAO
    Laparoscopic Bone Anchor Urethropexy Instrument Kit NWN
    Instruments, Surgical, Cardiovascular DWS
    Bit, Drill HTW
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Kit, Surgical Instrument, Disposable KDD
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Staple, Fixation, Bone JDR
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tamp HXG
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Tray OJH
    Orthopedic Manual Surgical Instrument LXH
    Trephine HWK
    Template HWT

    Proprietary Names

    215-001 Axial Torque Driver 212 Axial Torque Driver Series 412 Fixed Driver 214 Axial Torque Driver Series 218-020 Torque Limiter 212-065 Axial Torque Driver 212-052 Axial Torque Driver 212-033 Axial Torque Driver 212-054 Axial Torque Driver 214-026 Axial Torque Driver 214-014 Axial Torque Driver 212-096 Axial Torque Driver 214-029 Axial Torque Driver 212-008C Axial Torque Driver 212-084 Axial Torque Driver 215-007 Axial Torque Driver 212-066 Axial Torque Driver 212-076 Axial Torque Driver 214-024 Axial Torque Driver 218-023 Torque Limiter 212-083 Axial Torque Driver 214-003 A Axial Torque Driver 212-042 Axial Torque Driver 212-037 Axial Torque Driver 212-019 Axial Torque Driver 212-011 Axial Torque Driver 212-081 Axial Torque Driver 214-030 Axial Torque Driver 212-050 Axial Torque Driver 214-031 Axial Torque Driver 212-045 Axial Torque Driver 214-012 Axial Torque Driver 212-061 Axial Torque Driver 212-082 Axial Torque Driver 212-102 Axial Torque Driver 212-048 Axial Torque Driver 212-093 Axial Torque Driver 214-032 Axial Torque Driver 212-100 Axial Torque Driver 218-029 Torque Limiter 212-032 Axial Torque Driver 212-029 Axial Torque Driver 212-069 Axial Torque Driver 212-043 Axial Torque Driver 212-007C Axial Torque Driver 212-056 Axial Torque Driver 212-079 Axial Torque Driver 212-047 Axial Torque Driver 212-087 Axial Torque Driver 212-051 Axial Torque Driver 214-008 Axial Torque Driver 212-046 Axial Torque Driver 212-030 Axial Torque Driver 212-058 Axial Torque Driver 212-040 Axial Torque Driver 212-041 Axial Torque Driver 214-028 Axial Torque Driver 212-094 Axial Torque Driver 212-053 Axial Torque Driver 212-021 Axial Torque Driver 218-031 Torque Limiter 212-090 Axial Torque Driver 214-023 Axial Torque Driver 212-063 Axial Torque Driver 212-085 Axial Torque Driver 214-022 Axial Torque Driver 212-057 Axial Torque Driver 212-016 Axial Torque Driver 212-013 Axial Torque Driver 212-038 Axial Torque Driver 212-039 Axial Torque Driver 212-105 Axial Torque Driver 218-022 Torque Limiter 214-006 B Axial Torque Driver 212-092 Axial Torque Driver 218-025 Torque Limiter 212-071 Axial Torque Driver 212-095 Axial Torque Driver 212-018 Axial Torque Driver 212-004C Axial Torque Driver 214-027 Axial Torque Driver 212-107 Axial Torque Driver 212-099 Axial Torque Driver 212-106 Axial Torque Driver 214-035 Axial Torque Driver 215 Axial Torque Driver Series 218 Torque Limiter Series 200-010-F Torque Limiter 212 Axial Torque Driver 207-012 Torque Limiter 207-014 Torque Limiter Hex Key Series 100052-062 HEX Key 218-027 Torque Limiter 100934-001 Cap 100512-001 HEX Key 100148-002 HEX Key 214-002-A Axial Torque Driver 214-033 Axial Torque Driver 214-015 Axial Torque Driver 219-TXAX-013 Torque Driver 100054-001 HEX Key 218-028 Torque Limiter 212-015C Axial Torque Driver 228 -TXRX-002 TruPWR Torque Limiting Attachment, 14Nm 228-TXRX-001 TruPWR Torque Limiting Attachment, 12 Nm 227-TXRX-001 Series 90 inch pound Torque Limiting Attachment 228 - TXRX-003 TruPWR Torque Limiting Attachment, 6Nm 225 In-Line Torque-Driver with Torque-Fast® 230 Large or Offset T-handle Torque Driver with Torque-Fast® 905-001 Lumbar Sterile Instrument Kit 219 Medium Axial HandleTorque Driver 806 Fixed Driver Series 801-001 Instrument Kit 940 Instrument Kit Series 925 DRP Removal Driver System 926 DRP Template System Series 219-TXAX-001 Medium Axial Handle Torque Driver 803 Instrument Kits 922 DRP Instrument System Series 802 Instrument Kits (802-004) 802 Instrument Kits (802-001) 963 NX Nail Accessory Kit (963-001) 940 Instrument Kit (940-004) 919 Instrument Kits (919-002) 921 Instrument Kit (921-004) 960 NX Nail Instrument Kit (960-002) 806 Fixed Driver (806-003) 960 NX Nail Instrument Kit (960-003) 940 Instrument Kit (940-002) 963 NX Nail Accessory Kit (963-002) 806 Fixed Driver (806-005) 806 Fixed Driver (806-008) 812 T Handle Fixed Driver Series 919 Instrument Kits (919-001) 802 Instrument Kits (802-008) 976 T10 Driver Kit, AO 921 Instrument Kit (921-002) 812 T Handle Fixed Driver (812-001) 801 Instrument Kit (801-003) 806 Fixed Driver (806-004) 803 TruTORQ Adaptor Instrument Kit (803-003) 219-TXAX-011 Torque Driver 802 Instrument Kits (802-007) 803 TruTORQ Adaptor Instrument Kit (803-001) 803 TruTORQ Adaptor Instrument Kit (803-002) 219-TXAX-012 Torque Driver 805-001 Instrument Kit 802 Instrument Kits (802-003) 960 NX Nail Instrument Kit (960-001) 802 Instrument Kits (802-005) 921 Instrument Kit (921-001) 921 Instrument Kit (921-003) Orthopedic Cannulated Nail Instrument Pack (964-003) 806 Fixed Driver (806-009) 963 NX Nail Accessory Kit (963-004) 219-TXAC-006 Torque Driver 218-036 Torque Limiter 963 NX Nail Accessory Kit (963-006) 963 NX Nail Accessory Kit (963-005) 802 Instrument Kits (802-009) 940 Instrument Kit (940-001) 963 NX Nail Accessory Kit (963-003) Palm Handle, 2 mm Hex Torque Limiting Instrument (218-035) 921 Instrument Kit (921-005) 960 NX Nail Instrument Kit (960-004) 960 NX Nail Instrument Kit (960-006) 940 Instrument Kit (940-003) 960 NX Nail Instrument Kit (960-005) 806 Fixed Driver (806-002) 801 Instrument Kit (801-005) 803 TruTORQ T-Handle Instrument Kit (803-004) Transverse PROstep Calcaneal Guide (999-001) Orthopedic Cannulated Nail Instrument Pack (964-002) Orthopedic Cannulated Nail Instrument Pack (964-001) TruTORQ Medium Axial Handle, Sterile, Single Use, With T8 (1010) 801 Instrument Kit (801-007) 961 NX Nail Sizing Template

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device