FDA Registration
Active
🇮🇱 Israel
MEDIPLAST ISRAEL LTD
Reg #: 3008729892
·
FEI: 3002807555
·
Expires 2026
Products
42
Proprietary Names
82
Establishment Types
1
Classifications
42
Registration Details
- Registration Name
- MEDIPLAST ISRAEL LTD
- Registration Number
- 3008729892
- FEI Number
- 3002807555
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7 Ha Yarkon Street, Industrial Area
- City
- Yavne Tel Aviv
- Country
- IL
Owner / Operator
- Firm Name
- Mediplast Israel Ltd.
- Operator Number
- 10042357
- Address
- 7 Ha'Yarkon Street, Industrial Area
- City
- Yavne
- State
- Tel Aviv
- Postal Code
- 81227
- Country
- IL
- Correspondent
- George Hattub
US Agent
- Business Name
- Medicsense USA LLC
- Contact Name
- George Hattub
- Address
- 291 Hillside Ave
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2022-05-02 |
| Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | PBQ | Class 2 | Obstetrics/Gynecology | No | 2026-01-10 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-01-22 |
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2023-09-09 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2023-09-09 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2017-12-10 |
| Implanted Tibial Electrical Urinary Continence Device | QXM | Class 2 | Gastroenterology, Urology | No | 2023-09-09 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2025-08-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-12-04 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-07-22 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2017-12-10 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2015-06-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-05-19 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2023-05-19 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2026-01-10 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2022-02-07 |
| Staple, Absorbable | MNU | Class 2 | Orthopedic | No | 2024-12-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-12-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-08-22 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-06-14 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-12-04 |
| Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed | QPQ | Class 2 | Orthopedic | No | 2021-08-08 |
| Massager, Vacuum, Light Induced Heating | NUV | Class 2 | General, Plastic Surgery | No | 2019-07-22 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2025-07-30 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-07-30 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2026-01-10 |
| Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | SCZ | Class 2 | Cardiovascular | No | 2024-12-10 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-07-16 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2018-04-18 |
| Diagnostic Low Electric Field | OEE | Class 3 | Unknown | No | 2019-12-07 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2017-03-21 |
| Administration Set Securement Device | PUK | Class 1 | General Hospital | No | 2026-01-10 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2020-09-22 |
| Mr-Guided Focused Ultrasound System | POH | Class 3 | Unknown | No | 2022-10-23 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2023-09-19 |
| Injector, Fluid, Non-Electrically Powered | KZE | Class 2 | General Hospital | No | 2025-07-30 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2023-03-18 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2023-03-18 |
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | Class 2 | Gastroenterology, Urology | No | 2020-11-05 |
| Mountable Electromechanical Surgical System For Transluminal Approaches | QNM | Class 2 | General, Plastic Surgery | No | 2021-08-30 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2023-09-09 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2022-05-27 |
Proprietary Names
LungVision Tool
EnPlace
OSSIOfiber® Trimmable Fixation Nail, 4x100mm, Cannulated
BioProtect Balloon Implant System
IceSphere 1.5 CX Cryoablation needle
OSSIX Bone
Revi Implant
Vial2Bag Advanced® 20mm Admixture Device
OSSIO® Pin Product Family; OSSIOfiber® Trimmable Fixation Nail
Holder
IceRod 1.5 CX 90 Cryoablation Needle
elos Plus
Vial2Bag Advanced® 13mm Admixture Device
IceSphere 1.5 90 Cryoablation Needle, IceSphere 1.5 Cryoablation Needle
OSSIX® VOLUMAX
Name
Plasma Shield Disposable Part
MG412113- OnGuard Spike Port Adaptor CSTD.US
IceForce 2.1 CX L Cryoablation Needle, IcePearl 2.1 CX L Cryoablation Needle
APX 200
OSSIOfiber® Trimmable Fixation Nail, Cannulated
OSSIOfiber® Compression Staple
Closed antineoplastic and hazardous drug reconstitution and transfer system
OSSIOfiber® Compression Screw
Profound Matrix Cartridges
OSSIOfiber® Suture Anchor 2.5-3.5 mm
Introducer
OSSIOfiber® Suture Anchor
OSSIOfiber Compression Staple
CO2RE
InSpace Subacromial Tissue Spacer System
VellaShape II
V20 System With V-FR Handpiece
V10 System With V-FR Handpiece
V30 System With V-FR Handpiece
EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
IcePearl 2.1 CX Needle, IceForce 2.1 CX Cryoablation Needle
OSSIX® PLUS
IceRod Plus Needle, IceRod Plus 90 Degree Needle, IceRod Plus 90 Needle
ULTRA Pulse Alpha CO2 Laser System, Delivery Devices and Accessories
ShortCut
Viola
OSSIOfiber® Interference Screw
CleanSweep Closed Suction System
OSSIX Breeze
OSSIOfiber® Trimmable Fixation Nail
TL10
OSSIOfiber® Threaded Trimmable Fixation Nail
MarginProbe Probe
MG412166- OnGuard 2 CSTD BAG ADAPTOR CP (BACP)
Amsel Occluder Device
Administration Set Securement Device
Needle, hypodermic, single lumen
Xpeeda D/S/L; Sterile Aspiration Tubing
ProSense Cryoablation console and cryoprobes
Exablate 4000 (Exablate Neuro) Proprietary name of the sterilized accessory: PFK (Patient Fixation Kit)
Endymed Pro Skin Treatment System; iFine; Shaper3D
BeBack Crossing Catheter
IceRod 1.5 CX 90 Needle, IceRod CX 90 MultiPack
OSSIOfiber® Hammertoe Fixation System; OSSIOfiber® Hammertoe Fixation Implant
AirGent
eTwo
Composite Removable Sinus Stent System
iTIND
OSSIOfiber Compression Screw, 3.5mm
Instrument ARM as part of Hominis Surgical System
AcuPulse CO2 Laser System, Delivery Devices and Accessories
IceRod Prostate Kit, IceRod Needle, IceRod MRI Needle, IceSeed MRI Needle
MG412170- OnGuard 2 CSTD 20mm Vial Adaptor SL and 13mm Convertor
MG412160- OnGuard 2 LUER LOCK ADAPTOR
MG412164- OnGuard 2 SYRINGE ADAP.LOCK
MG412175- OnGuard 2 Vial Adaptor Multipack 10 units
MG412174- OnGuard 2 Syringe Adaptor Lock II
MG412143- OnGuard 2 BAG ADAPTOR SP
MG412177- Onguard 2 Syringe Adaptor Sterile Replacement Caps
MG412161- OnGuard 2 20MM VIAL ADAPTOR
MG412171- OnGuard 2 CSTD 20mm vial Adaptor II and 13mm convertor
MG412186- OnGuard 2 BAG ADAPTOR SP II
MG412187- OnGuard 2 Vial Adaptor Multipack 5 units
MG412163- OnGuard 2 SYRINGE ADAPTOR
Pure by EndyMed
Vial2Bag Advanced 20mm Admixture Device
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)