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
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2002-07-06 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1991-02-11 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2017-04-11 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2006-10-11 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 1994-08-11 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 1991-02-28 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2016-12-15 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2002-07-06 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1993-01-01 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2006-07-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2006-10-11 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2002-07-06 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2022-08-31 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2006-10-18 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1991-02-12 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2010-03-15 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2002-07-06 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 1993-01-01 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2002-07-27 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1991-02-21 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1991-02-12 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2002-07-06 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2004-01-07 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 1991-02-21 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2009-02-02 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2003-12-15 |
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