FDA Registration Active 🇮🇸 Iceland

Ossur Iceland ehf.

Reg #: 3003764610 · FEI: 3003764610 · Expires 2026
Products
26
Proprietary Names
527
Establishment Types
3
Classifications
26

Registration Details

Registration Name
Ossur Iceland ehf.
Registration Number
3003764610
FEI Number
3003764610
Status
Active
Expiry Year
2026
Initial Importer
No
Address
GRJOTHALS 5
City
REYKJAVIK
Country
IS

Owner / Operator

Firm Name
OSSUR Americas
Operator Number
9026971
Address
200 Spectrum Center Drive, Suite 700
City
Irvine
State
CA
Postal Code
92618
Country
US

US Agent

Business Name
Ossur
Contact Name
Katla Axelsdottir
Address
200 Spectrum Center Drive, Suite 700
City
Irvine
State
CA
ZIP
92618
Country
US
Phone
949 3823833

Products

Device Name Product Code
Orthosis, Lumbo-Sacral IPY
Splint, Hand, And Components ILH
Hand, External Limb Component, Powered IQZ
Tape And Bandage, Adhesive KGX
Pack, Hot Or Cold, Water Circulating ILO
Splint, Clavicle IQJ
Cover, Limb IPM
Joint, Ankle, External Brace ITW
Orthosis, Cervical IQK
Component, External, Limb, Ankle/Foot ISH
Bandage, Elastic FQM
Pack, Hot Or Cold, Reusable IME
Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
Orthosis, Limb Brace IQI
Sling, Arm ILI
Orthosis, Thoracic IPT
Prosthesis, Thigh Socket, External Component ISS
Joint, Knee, External Brace ITQ
Joint, Knee, External Limb Component ISY
Binder, Abdominal FSD
Orthosis, Lumbar IQE
Support, Arm IOY
Hand, External Limb Component, Mechanical IRA
Shoe, Cast IPG
Joint, Hip, External Brace ITS
Orthosis, Corrective Shoe KNP

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 Sling and Swathe Shoulder Abduction Sling Formfit Shoulder Brace with Abduction Formfit Shoulder Brace with External Rotation Formfit Shoulder Brace Formfit Shoulder Brace with Airplane High Arm Sling Padded Strap Shoulder Immobilizer External Rotation Pillow Axilla Pillow Pediatric Universal Arm Sling Premium Shoulder Immobiliser Premium Shoulder Immobilizer Premium Contact Closure Arm Sling Premium Padded Arm Sling Buckle Closure Arm Sling Bergschultz Universal Arm Sling Miami TLSO 456 Miami TLSO 464 Aerofit® Vents Iceross Direct Casting Liner Aspire Locking Iceross Dermo Cushion Iceross Comfort Locking Iceross Seal-In X Ossur Brim Iceross Seal-In X5 Iceross Sleeve Iceross Socks First Direct Socket Tool Kit Iceross Dermo Locking Relax Cushion Iceflex Balance Sleeve AKOS Iceross Curvemaster Iceross Sport Locking Iceross Dermo Uniform Cushion Iceross Seal-In X seals Iceross Seal-In X TF Protect Cushion Iceross Interface Sheath Soft C Iceross Distal Cup Sensitive Locking Iceross Seal-In X5 TF Iceross Post-Op TF Iceform Sleeve Iceross Stabilo Junior Locking Iceross Seal-In X Locking Protect Locking Iceross Original Locking 4Seal Classic Iceross Dermo Uniform Locking Iceross Post-Op TT Iceross Transfemoral Locking Iceross Dermo Seal-In Relax Locking Iceform Locking Liner Iceross Synergy Locking Connect TF Iceross Dermo Junior Locking Relax Transfemoral Iceform Cushion Liner Iceross Synergy Cushion Iceross Activa Cushion Iceross Seal-In Transfemoral Iceross Upper-X Locking Iceross Comfort Cushion Iceross Seal-In V Iceross Pads Genu Sleeve Aspire TF Locking Definitive Socket TF Check Socket TT Protector Sleeve 4Seal Senso Iceross Seal-In Socks Pressure Pads Knee Lanyard kit for Connect TF Check Socket TF AeroFit Seal-In Definitive Socket TT IcePro Socket TF Diagnostic Direct Socket IcePro Socket TT Diagnostic AeroFit Socket IcePro Socket TT IcePro Socket TF Iceross Seal-In X Locking TF CTi Mission Oversleeve Neoprene FX Patella Stabilizer Ski boot attachment Unloader One® X Custom Formfit OA Ease Rebound® Cartilage Custom Flex MX Gear Guards CTi 3 Formfit Knee Hinged Lateral J Neo AMS Wrap OTS Rebound® ACL Premium Elastic Knee Support SportSleeve AMS Sleeve Formfit Knee Braces MX Patella Cup Rebound Post Op Knee Suspension Strap Kit AMS Wrap Silicone AMS Wrap Unloader One X Formfit Knee MCL Rebound® Cartilage Flexion Stop Kit Extreme Lycra Liner CTi3 PCL Strap Anti-Migration System (AMS) Wrap EVA Neoprene Knee Sleeve CTi OA Padded Sports Oversleeve AMS Wrap NEO - CTi® Custom Formfit Knee Immobilizer Neoprene Hinged Knee Support Rebound® ACL Custom Elastic Calf Suspension Strap Paradigm Custom SoftSleeve CTi Custom Non-elastic Thigh Strap Formfit Hinged Knees MX Kit Rebound Knee Immobilizer Universal CTi3 Impact Guard Thigh/Calf liner EVA Exoform Knee Immobilizer Patella cup Softsleeve C180 Rocket Neoprene Knee Support with Stabilized Patella Unloader Custom Condyle Pad Kit Neoprene Wraparound Hinged Knee Support Knee shield Formfit Pro Knee Rebound® PCL Custom Unloader One Plus Unloader Spirit Undersleeve Neoprene Undersleeve Formfit ROM Knees Formfit Pro Knee OA Unloader One Formfit Post-Op Knee Rebound® PCL Unloader One Custom Rebound Knee Strap and Pad Kit OA Ease Formfit Knee Buttress Extension Stop Kit OA Move PCL Kit for CTi® Locking Knee Haiti Knee OP4 Knee Balance Knee OM8 SE Balance Knee OFM1 Cheetah Knee OP5 Knee OHP3 Knee Balance Knee OFM1 SE Paso Knee Balance Knee OFM2 OP2 Knee SE Shin Fairing, Black Shin Ferrule For Balance Knee Knee cap, jr Season Guard Aspire M2 Knee caps Aspire H1 Aspire M3 Aspire M1 Junior Shin Ferrule Aspire P1 Navii Total Knee 2000 Total Knee 1900 Rheo Knee XC Ossur Logic Shin Fairing, Black ( 2100) Power Knee Power Knee Battery Total Knee 2100 Mauch Knee Balance Knee OFM2 SE Total Knee Junior Rheo Knee Elastic Abdominal Binder Universal Abdominal Binder Universal Elastic Rib Belt Temporary Hernia Support Formfit Back Support Air Formfit Back Support OAM Rigid Lumbar Formfit Pro Back Miami Lumbar Posteo Posterior panel Standard Posterior panels with Lateral support Formfit® Back VS Formfit Pro Elbow Rebound Post-Op Elbow Tennis Elbow Support with Hot/Cold Therapy Gel Pad Formfit Tennis Elbow AirForm Tennis Elbow Support Livingskin Partial finger Livingskin Toe Livingskin Full hand Livingskin Finger band Livingskin Below elbow Livingskin Partial hand Livingskin Foot Livingskin Full finger Livingskin Above Elbow Livingskin PIPDriver® MCPDriver® ThumbDriver® GripLock Finger® Mesh Top Post-Op Shoe Female Pediatric Cast Sandal with Rocker Sole Soft Top Post-Op Shoe DH Offloading Post-Op Style shoe Square Top Post-Op Shoe Canvas Rocker Bottom Cast Shoe Mesh Top Post-Op Shoe Male Unloader Hip Rebound Hip Rehab Kit Rebound Hip Rebound Hip OR Kit Belt Extender SoftWalk Insoles

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device