Ossur Iceland ehf.

FDA Device Registration & Listing · REYKJAVIK, IS · Registration 3003764610

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003764610
FEI Number
3003764610
Entity Name
Ossur Iceland ehf.
City/State/Country
REYKJAVIK, IS
Establishment Address
GRJOTHALS 5, REYKJAVIK 110, IS
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OSSUR Americas (Owner Number: 9026971)
Owner / Operator Contact Address
200 Spectrum Center Drive, Suite 700, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Miami LSO Posterior panels Non-lordotic posterior panels Anterior panels AirForm Inflatable Back Support Form Fit Advanced Back Support Formfit Wrist & Forearm Formfit Wrist Formfit Pediatric Thumb Spica Formfit Wrist and Forearm Universal Formfit Pediatric Wrist Universal Formfit Pro Wrist Wrist Brace Spectra Wrist Brace Exoform Carpal Tunnel Wrist Formfit Universal Wrist Formfit Universal Thumb Formfit Thumb Universal Thumb Splint Exoform Wrist Thumb Spica i-Limb Ultra Demo-limb i-LIMB Skin Active i-Limb Quantum i-Digits i-Digits Quantum i-Limb Ultra Titanium i-Digits Access i-Limb Access My Biosim Virtu-limb i-LIMB Skin Natural Biosim Pro i-LIMB Skin Contour My i-Limb i-Limb access titanium Biosim Tape and Bandage, Adhesive Cold Rush Compact Cold Rush Cold Rush Device Front Closure Clavicle Support Figure 8 Clavicle Splint Thigh Sleeve Relax Night Care Stump Shrinker i-limb skin natural Comfort SCS i-limb skin match Volume Compensation Sock Formfit Night Splint Equalizer Pre-Inflated Air Walker Rebound Diabetic Walker Form Fit Equalizer Walker Low Top Formfit Walker Air Low Top Formfit Ankle with SpeedLace Pediatric Walker Formfit Ankle with Figure 8 Rebound Foot Up Formfit Ankle Formfit Walker Low Top Formfit® Walker Air Formfit Night Splint Posterior Formfit Walker DH OffLoading Walker Formfit Honeycomb Ankle Stirrup Adhesive Insole for wedge Durable Weather Cover Exoform Dorsal Night Splint Formfit Pro Ankle AirForm Pre-inflated Ankle Stirrup Formfit Ankle Stirrup Foam Wedge Formfit Air Ankle Stirrup Rebound Air Walker AirForm Night Splint Foot Up Achilles heel wedge Formfit Gel Ankle Stirrup Hygiene Cover Metal Strut Air Walker Disposable Weather Cover Width Extender kit Strap Extension AFO Light Equalizer Pre-Inflated Air Walker Low Top Equalizer Air Walker Low Top Equalizer Air Walker Rebound Ankle Brace Equalizer Walker Rebound Air Walker LT AFO Leaf Spring AFO Dynamic GameDay Lace Up Equalizer Walker Low Top Miami J® Select Tabs Rep Fit Philadelphia Tracheotomy Collar Patriot Collar NecLoc Kids Miami JTO Thoracic Extension Occian Back Miami Jr Papoose Miami J NecLoc Miami J Select Philadelphia Stabilizer Philadelphia Adjustable Tracheotomy Collar Universal Cervical Collar Philadelphia Liner 4-Hole adapter Double Adapter Double Pyramid Receiver Icelock® 700 Adapters Double Pyramid Adapter Pylon Kit SACH Foot Adapter Height adjustable pylon Threaded Adapter Foot cover FCT Icelock® 721 Ratchet Pin Adapter Pro-Flex Modular Icelock® 562 Hybrid Unity Connector K2 Sensation Vari-Flex Modular Cheetah Xplore Icelock® 544 Expulsion Valve Unity for Pro-Flex Velocity Plates Icelock® 125 Ratchet Icelock® 544 EP Kit Pro-Flex LP Unity for Balance Foot S Torsion Velocity Adapters Foot cover FSM Icelock® 621 Ratchet LP Vari-Flex Icelock 214 Clutch AK Offset Nike SoleX Attachment Kit Torsion Shock Adapter Pro-Flex ST Foot Cover FSL Icelock® 331 Lamination Sockets Proprio Foot Unity for Proprio Foot Height Adjustable Pylon Nike Sole Balance Foot J Icelock® 400 BOA-System Lamination Re-Flex Shock Unity Kit for TF Chopart Icelock® 544 Reservoir Kit Icelock® 631 Lanyard Adaption Kit Cheetah Xpanse Icelock® 214 4-Hole Clutch Icelock® 544 Expulsion Plate Unity for LP Vari-Flex Continuous Cosmetic Foam Cheetah Xtend Icelock® 544 LL Kit Icelock 562 Hybrid Unity Nike SoleX Icelock® 621 Ratchet Adaption Kit Unity for Pro-Flex XC Unity for Balance Foot S Dual Density Shin Fairing Icelock® 600XM Ratchet Knee Rotation Adapter Flex-Foot Balance Flex-Foot Junior Icelock® 641 Valve Adaption Kit Flex-Foot Assure Flex-Foot Cheetah® Icelock® 544 Reservoir Plate Icelock® 641 Valve Foot cover FJS Icelock® 214 Clutch DS Icelock® 773 Male Pyramid AL Pro-Flex Pivot Icelock 400 Standard Lamination Nike Spike Pad Unity Shin Foam Foot cover FSE Icelock® 234 Lanyard Pro-Flex XC Foot cover FST Male Pyramid Adapter Flex-Symes Icelock® 721 Ratchet Pro-Flex LP Torsion Balance Foot S Foot cover FSF Icelock® 400 Single / Double Lamination Icelock® 544 Unity Kit Icelock® 234 Lanyard Adaptation Kit Pro-Flex XC Torsion Talux Unity Valve Flex-Foot® Balance with D/P Flexion Flex-Run Icelock® 651 Smooth Calf cosmesis Icelock® 544 E2 Connector Kit Icelock® 552 Expulsion Valve TF Vacu Valve Flex-Run Junior Icelock® 651 Smooth Adaption Kit Pro-Flex LP Align Icelock® 562 Hybrid Unity DS K2 Sensation® with D/P Flexion Cheetah Xcel Icelock® 211 Clutch Icelock® 544 Expulsion Kit Unity for Flex-Foot Assure & Balance Foot J Single Density Shin Fairing Block Cheetah Xtreme Icelock® 544 LL Plate Icelock® 631 Lanyard Cheetah Xplore Junior Icelock® 544 Expulsion Valve Kit Unity for Pro-Flex LP Velocity Kits Black Spectra Socks Icelock® 544 E2 Connector Icelock® 551 Expulsion Valve Unity® Valve TT Balance Foot S Torsion Icelock® 400 Single Lamination with 4-hole Adapter Icelock® 544 Unity Plate Unity® Valve TF Cheetah Xceed Icelock® 562 Hybrid Passive Vacuum DS Vari-Flex Junior Cheetah Junior Icelock® 562 Hybrid Passive Vacuum Vari-Flex Icelock® 125 Ratchet Fabrication Kit Without Braid Icelock® 544 EP Plate Unity for FF Balance & K2 Sensation Discontinuous cosmetic foam Aspire Foot Icelock® 331 Thermoplastic Sockets Re-Flex Rotate Unity for Vari-Flex Pro-Flex Terra Flexion Plate SandalFix FSW Foot Cover Ratchet Lock Body Pro-Flex LP Junior Icelock® 600 Adapters Icelock® 850 Hybrid for Laminated Sockets Icelock® 850 Hybrid for Direct Socket Icelock® 200 Adapters Shift Adapter Insert for Prong Pronged adapter Single Adapter Icelock® 850 Hybrid for 4-Hole Sockets Pylon Tube Clamp Socket Adapter Stockinette Hot/Cold Therapy Gel Pad Ucast Procast Ossur Rigid Dressing Vacuum Pump for Rigid Dressing Woodcast Rebound Dual Rebound Dual ST Formfit Pro Knee Flite Formfit Tracker Rebound Dual Recover Rebound Dual Basic Rebound DUAL Custom Rebound Dual Basic ST Rebound DUAL ST Custom NEURO SWING AFO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2002-07-06
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 1991-02-11
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2017-04-11
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2006-10-11
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 1994-08-11
IQJ Splint, Clavicle Physical Medicine Class 1 890.3490 1991-02-28
IPM Cover, Limb Physical Medicine Class 1 890.3025 2016-12-15
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2002-07-06
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 1993-01-01
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2006-07-13
FQM Bandage, Elastic General Hospital Class 1 880.5075 2006-10-11
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2002-07-06
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2022-08-31
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2006-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Katla Axelsdottir Business: Ossur Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

OSSUR Americas
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008395545 OSSUR Newburgh, NY, US
3008523132 Ossur Mexico Tijuana Baja California, MX
3010405373 Ossur Orlando Orlando, FL, US
3004161950 OSSUR EUROPE B.V. Eindhoven Noord-Brabant, NL
3006532285 Touch Bionics Ltd Livingston West Lothian, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3003849847 TIEN JIANG ENTERPRISE CO., LTD. TAINAN CITY, TW
3003829642 PANTYMED S.A. BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
3003573572 Electrostim Medical Services, Inc. Tampa, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003764610. Last updated year: 2026. Please use registration number 3003764610 when referencing this establishment in official correspondence.
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