Pollak (Intl.).ltd
Tel Aviv, IL
POLLAK (INTL.) .LTD appears in FDA device records in Tel Aviv, IL. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Pollak (Intl.).ltd between 1980 and 2000. The busiest year on record is 1980, with 28. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 28 |
| 1981 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000227 | UMBICUT | HFW | Substantially Equivalent | |
| K810049 | PEDICAT* | KMJ | Substantially Equivalent | |
| K810050 | VECAFIX* | KGX | Substantially Equivalent | |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | FLN | Substantially Equivalent | |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | FKK | Substantially Equivalent | |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | KDD | Substantially Equivalent | |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | FRQ | Substantially Equivalent | |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | EFQ | Substantially Equivalent | |
| K802021 | PEDIBAND CAT.#195-197 | NAD | Substantially Equivalent | |
| K802019 | SUTURE REMOVAL SET CAT.#906 | KDD | Substantially Equivalent | |
| K802016 | EYE APPLICATORS CAT.#980-983 | KXF | Substantially Equivalent | |
| K802013 | FIRST AID BANDAGE CAT.#198 OR 199 | KGX | Substantially Equivalent | |
| K802010 | GUAZE SWABS CAT.#251-300 (SIZE & PLY) | EFQ | Substantially Equivalent | |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | ILI | Substantially Equivalent | |
| K802005 | ABSORBENT PAD CAT.#729, 732, 730, 731 | EFQ | Substantially Equivalent | |
| K802004 | PROFILE SWAB CAT.#5273 & 5274 | KXG | Substantially Equivalent | |
| K802001 | LAP SPONGES CAT.#801-850 | KKX | Substantially Equivalent | |
| K801999 | GUAZE BALLS CAT.#601-720 | EFQ | Substantially Equivalent | |
| K801996 | GUAZE BANDAGES CAT.#101-169 | NAB | Substantially Equivalent | |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | GEN | Substantially Equivalent | |
| K802023 | CULSWAB CAT.#978 & 979 | JTW | Substantially Equivalent | |
| K802020 | PREP SET CAT.#908 | KXF | Substantially Equivalent | |
| K802015 | FINGER PAINGUARD CAT.#193-194 | FQM | Substantially Equivalent | |
| K802012 | TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 | KNX | Substantially Equivalent | |
| K802008 | BREAKING CAST WIRE CAT.#1112-1115 | Substantially Equivalent | ||
| K802003 | PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 | LDQ | Substantially Equivalent | |
| K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 | FMH | Substantially Equivalent | |
| K801998 | STERILE EXAMINATION GLOVE #5121-5126 | FMC | Substantially Equivalent | |
| K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 | FMC | Substantially Equivalent | |
| K801995 | EYE PADS CAT.#581-599 | HMP | Substantially Equivalent | |
| K801990 | ELASTIC BANDAGE CAT.#182-186 (WIDTH) | FQM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3043585890 | 3043585890 | POLLAK (INTL.) .LTD | 52 Hamitnadev Street, Tel Aviv 6969048 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- FQMBandage, Elastic
- FKKClamp, Line
- HFWClamp, Umbilical
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FMHContainer, Specimen, Sterile
- KKXDrape, Surgical, Antimicrobial
- NADDressing, Wound, Occlusive
- GENForceps, General & Plastic Surgery
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- KDDKit, Surgical Instrument, Disposable
- KMJLubricant, Patient
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- HMPPad, Eye
- FMCPatient Examination Glove
- ILISling, Arm
- JTWSystem, Transport, Aerobic
- KGXTape And Bandage, Adhesive
- FRQTube, Levine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain