Data / Medical devices / Israel / Euroband Bioline LTD.
Euroband Bioline LTD.: FDA-registered device maker in INDUSTRIAL PARK EMEK HEFER Central, Israel, 26 510(k) clearances
Euroband Bioline LTD. is registered with the FDA (registration 9611024) in INDUSTRIAL PARK EMEK HEFER Central, Israel. It lists 44 device types. The FDA files 26 510(k) clearances under its listings, the newest dated April 27, 2000. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9611024
- FEI number
- 3002807170
- Address
- 31 Gesher Haetz ST. Industrial Park Emek Hefer, INDUSTRIAL PARK EMEK HEFER Central, Israel, 3877701
- Owner or operator
- Euroband Bioline Ltd (10047611)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 12, 2014
- Registered through
- 2026
- Brand names listed
- Adhesive tape and bandage, Biopsy Kit, Cast bandage, Container Specimen, Cotton Tipped Applicator, Dialysis Dressing Tray, Disposable medical Scissors, Dressing Change Tray 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2000 | K000227 | UMBICUT | HFW | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| December 30, 1992 | K914600 | NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| July 17, 1989 | K892389 | BIOPSY KIT | LRO | Unknown | I M, Inc. | accessdata.fda.gov |
| June 23, 1988 | K881363 | SYRINGE PREFILLED WITH WATER | KOD | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| April 27, 1988 | K880753 | UMBILICAL CORD CLAMP | HFW | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| May 8, 1987 | K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | NAD | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| December 10, 1985 | K854155 | STERILE SALINE SOLUTION | KMJ | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| January 10, 1984 | K833399 | SYRINGE | FMF | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| December 12, 1983 | K833435 | MULTI PURPOSE SYRINGE | FMF | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| September 1, 1983 | K831795 | FIRST AID KITS | KDD | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| July 19, 1983 | K831797 | HEMOSTATS | HRQ | Substantially Equivalent | I M, Inc. | accessdata.fda.gov |
| April 21, 1981 | K810049 | PEDICAT* | KMJ | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| October 31, 1980 | K802009 | FLOWCLAMP CAT.#1011 & 1012 | FKK | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| October 10, 1980 | K802017 | DRESSING CHANGE SET CAT.#910-930 | KDD | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 26, 1980 | K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | FRQ | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802021 | PEDIBAND CAT.#195-197 | NAD | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802019 | SUTURE REMOVAL SET CAT.#906 | KDD | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802016 | EYE APPLICATORS CAT.#980-983 | KXF | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802013 | FIRST AID BANDAGE CAT.#198 OR 199 | KGX | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802010 | GUAZE SWABS CAT.#251-300 (SIZE & PLY) | EFQ | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K802001 | LAP SPONGES CAT.#801-850 | KKX | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K801999 | GUAZE BALLS CAT.#601-720 | EFQ | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K801996 | GUAZE BANDAGES CAT.#101-169 | NAB | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 16, 1980 | K801991 | PLASTIC FORCEPS CAT.#1001-1010 | GEN | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 9, 1980 | K802020 | PREP SET CAT.#908 | KXF | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
| September 9, 1980 | K802003 | PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 | LDQ | Substantially Equivalent | Pollak (Intl.), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Forceps, General & Plastic Surgery
- All makers of Syringe, Piston
- All makers of Tape And Bandage, Adhesive
- All makers of Scissors, Medical, Disposable
- All makers of Forceps
Updated April 27, 2000. 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.