MEDIPLAST ISRAEL LTD

FDA Device Registration & Listing · Yavne Tel Aviv, IL · Registration 3008729892

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
3008729892
FEI Number
3002807555
Entity Name
MEDIPLAST ISRAEL LTD
City/State/Country
Yavne Tel Aviv, IL
Establishment Address
7 Ha Yarkon Street, Industrial Area, Yavne Tel Aviv 81227, IL
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Mediplast Israel Ltd. (Owner Number: 10042357)
Owner / Operator Contact Address
7 Ha'Yarkon Street, Industrial Area, Yavne, IL-TA 81227, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 OSSIOfiber® Suture Anchor ShortCut Viola OSSIOfiber® Interference Screw Name CleanSweep Closed Suction System OSSIX Breeze OSSIOfiber® Trimmable Fixation Nail OSSIOfiber® Trimmable Fixation Nail, Cannulated OSSIOfiber® Compression Screw TL10 OSSIOfiber® Threaded Trimmable Fixation Nail MarginProbe Probe MG412166- OnGuard 2 CSTD BAG ADAPTOR CP (BACP) Amsel Occluder Device Profound Matrix Cartridges OSSIOfiber® Suture Anchor Administration Set Securement Device Needle, hypodermic, single lumen Xpeeda™ D/S/L; Sterile Aspiration Tubing Name

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-05-02
PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use Obstetrics/Gynecology Class 2 884.4530 2026-01-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-01-22
OVB Hydrogel Spacer Radiology Class 2 892.5725 2023-09-09
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2017-12-10
QXM Implanted Tibial Electrical Urinary Continence Device Gastroenterology, Urology Class 2 876.5305 2023-09-09
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-08-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-12-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2022-12-04
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-07-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-05-19
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2017-12-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-05-19
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2023-05-19
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2026-01-10
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2022-02-07
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-07-01
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2024-12-10
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2026-01-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-06-14
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-07-07
MNU Staple, Absorbable Orthopedic Class 2 888.3030 2024-05-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-07-22
QPQ Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed Orthopedic Class 2 888.3630 2021-08-08
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2019-07-22
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2025-07-30
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2025-07-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-07-30
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2026-01-10
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2017-12-10
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2023-09-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-09-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-05-24
SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Cardiovascular Class 2 870.1254 2024-12-10
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-07-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-04-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2012-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-18
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2018-04-18
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2022-10-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-01-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-05-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-12
OEE Diagnostic Low Electric Field Unknown Class 3 N/A 2019-12-07
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2026-01-10
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2017-03-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-10-15
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-04-25
PUK Administration Set Securement Device General Hospital Class 1 880.5210 2026-01-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2020-09-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-05-19
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2015-06-15

Official Correspondent

George Hattub

US Agent Details

George Hattub Business: Medicsense USA LLC Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Mediplast Israel Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008729892. Last updated year: 2026. Please use registration number 3008729892 when referencing this establishment in official correspondence.
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