Data / Medical devices / Israel / Orta Medical Ltd
Orta Medical Ltd: FDA-registered device maker in TZUR YIGAL Central, Israel, 111 510(k) clearances
Orta Medical Ltd is registered with the FDA (registration 3013188547) in TZUR YIGAL Central, Israel. It lists 100 device types. The FDA files 111 510(k) clearances under its listings, the newest dated August 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013188547
- Address
- Bazelet 14, TZUR YIGAL Central, Israel, 44862
- Owner or operator
- ORTA MEDICAL LTD (10053784)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- January 11, 2017
- Registered through
- 2026
- Brand names listed
- Device, medical examination, ac powered, ENDO CATCH GOLD, ERA - OTOSCOPE, Gauze / sponge,nonresorbable for external use, Laparoscope, general & plastic surgery, LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, Non-surgical isolation gown, ORTA MEDICAL and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 111.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2024 | K240229 | Masimo W1 | DPS | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| March 10, 2023 | K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| August 12, 2022 | K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | FMK | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| October 21, 2020 | K201155 | PleurX Peritoneal Catheter System | PNG | Unknown | Care Fusion | accessdata.fda.gov |
| September 5, 2018 | K173665 | AMSafe Sure-Lok Needle-Free Connector | FPA | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| March 26, 2018 | K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 9, 2018 | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| February 16, 2018 | K172361 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 3, 2017 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| October 5, 2017 | K172093 | Reprocessed Covidien Trocar | NLM | Substantially Equivalent | Renovo, Inc. | accessdata.fda.gov |
| September 25, 2017 | K171442 | Exofin Fusion Skin Closure System | OMD | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| May 26, 2017 | K171294 | da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 5, 2016 | K163098 | Tri-Staple 2.0 Intelligent Cartridge | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 18, 2016 | K162584 | VersaOne Bladeless Trocar | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 16, 2016 | K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 12, 2016 | K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 5, 2016 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| February 9, 2016 | K152476 | Exofin High Viscosity Tissue Adhesive | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| October 29, 2015 | K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | KDJ | Substantially Equivalent | Baxter Healthcare | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 29, 2015 | K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 24, 2015 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 27, 2015 | K142929 | Ligasure Blunt Tip Sealer/Divider | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 18, 2014 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142600 | VIAL-MATE Adaptor | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| September 26, 2014 | K141380 | PROVOX FREEHANDS FLEXIVOICE | EWL | Substantially Equivalent | Atos Medical AB | accessdata.fda.gov |
| July 11, 2014 | K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | Substantially Equivalent | Welch Allyn | accessdata.fda.gov |
| February 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| January 22, 2014 | K133938 | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 23, 2013 | K132493 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 9, 2013 | K130796 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | MWI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 18, 2013 | K130717 | ENDO GIA RELOAD | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 16, 2012 | K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | MDB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 28, 2010 | K101276 | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 | MPN | Substantially Equivalent | Chemence Medical Products, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101385 | DUAL LUER LOCK CAP, MODEL 2C6250 | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 4, 2010 | K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| May 10, 2010 | K100257 | VLOC9ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| April 9, 2010 | K091720 | SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Sklar Corp. | accessdata.fda.gov |
| March 10, 2010 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | FPA | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| January 21, 2010 | K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| November 12, 2009 | K093402 | AUTOSUTURE EEA ORVIL | GDW | Substantially Equivalent | Surgical Devices, A Global Business Unit Tyco | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 26, 2009 | K082662 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, Tyco Healthcare Group LP | accessdata.fda.gov |
| May 23, 2008 | K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| October 5, 2006 | K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) | GCJ | Substantially Equivalent | New Wave Surgical Corporation | accessdata.fda.gov |
| August 11, 2006 | K060978 | COAGUCHEK XS SYSTEM | GJS | Substantially Equivalent | Roche Diagnostics | accessdata.fda.gov |
| March 31, 2006 | K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| February 23, 2006 | K050757 | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE | KMF | Substantially Equivalent | Chemence Medical, Inc. | accessdata.fda.gov |
| June 1, 2005 | K050947 | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE | GAW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 24, 2004 | K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 22, 2003 | K031307 | FERRIS POLYMEM SILVER WOUND DRESSING | FRO | Substantially Equivalent | Ferris Mfg. Corp. | accessdata.fda.gov |
| May 29, 2003 | K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030664 | AMSURE FOLEY INSERTION TRAY | FCM | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030592 | GAMBRO POLYFLUX, MODEL 140H, 170H, 210H | KDI | Substantially Equivalent | Gambro Renal Care Products | accessdata.fda.gov |
| May 8, 2003 | K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | JKA | Substantially Equivalent | Bd Vacutainer Systems Preanalyical Solutions | accessdata.fda.gov |
| April 4, 2003 | K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | GEI | Substantially Equivalent | Radionics, Inc. | accessdata.fda.gov |
| March 26, 2003 | K024240 | BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS | JSM | Substantially Equivalent | Bd | accessdata.fda.gov |
| August 15, 2002 | K022347 | MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| January 3, 2002 | K011564 | NEOLEAD | DRX | Substantially Equivalent | Neotech Products, Inc. | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 13, 2001 | K013362 | AUTOJECT 2 | KZH | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| September 6, 2001 | K012539 | VERASTEP | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| April 2, 2001 | K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| July 20, 2000 | K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| January 12, 2000 | K992719 | AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE | KNT | Substantially Equivalent | Amsino Intl., Inc. | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| April 29, 1999 | K990906 | FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER | KMF | Substantially Equivalent for Some Indications | Ferris Mfg. Corp. | accessdata.fda.gov |
| December 21, 1998 | K983909 | MIR SPIROBANK SPIROMETER | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| November 25, 1998 | K983045 | AMIELLE | KXP | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| June 29, 1998 | K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | FYD | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 4, 1997 | K973899 | UNIFINE PENTIPS | FMI | Substantially Equivalent | Owen Mumford USA, Inc. | accessdata.fda.gov |
| September 19, 1997 | K972415 | MINISITE*BIPOLAR FORCEPS** DEVICE | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY | KPE | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 5, 1995 | K944602 | VALLEYLAB FORCE FX | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| April 4, 1995 | K950461 | WELCH ALLYN OPHTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| February 14, 1995 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| February 10, 1995 | K950188 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 6, 1994 | K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| December 6, 1994 | K931052 | METRICIDE 28 | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| December 6, 1994 | K930284 | METRICIDE | MED | Substantially Equivalent | Metrex Research Corp. | accessdata.fda.gov |
| November 9, 1994 | K945260 | E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| June 9, 1994 | K934288 | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR | CBH | Substantially Equivalent | Neo-Tech, Inc. | accessdata.fda.gov |
| June 7, 1994 | K932913 | FERRIS POLYMEM HYDROPHILIC WOUND DRESSING | KMF | Substantially Equivalent for Some Indications | Ferris Mfg. Corp. | accessdata.fda.gov |
| February 22, 1994 | K932512 | MULTI-PORT MANIFOLD | FMG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| January 26, 1994 | K935426 | PREPERITONEAL DISTENTION BALLOON SYSTEM | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| November 2, 1993 | K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Vitaid, Ltd. | accessdata.fda.gov |
| July 9, 1993 | K924011 | ORIGIN BLUNT TIP SURGICAL TROCAR | GCJ | Substantially Equivalent | Origin Medsystems, Inc. | accessdata.fda.gov |
| May 29, 1992 | K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH | FTL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 28, 1990 | K893221 | MODEL 8500 HAND HELD PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
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Updated August 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.