Pollak (Intl.), Ltd.
Medical device manufacturer in Rosh Ha'Ayin, IL.
31510(k) clearances
0PMA approvals
0recalls
Device types
- EFQ Gauze/Sponge, Internal 4
- FMC Patient Examination Glove 2
- KXF Applicator, Absorbent Tipped, Non-Sterile 2
- FQM Bandage, Elastic 2
- KDD Kit, Surgical Instrument, Disposable 2
- KGX Tape And Bandage, Adhesive 2
- KKX Drape, Surgical, Antimicrobial 1
- HFW Clamp, Umbilical 1
- KMJ Lubricant, Patient 1
- FLN Monitor, Electric For Gravity Flow Infusion… 1
- FKK Clamp, Line 1
- FRQ Tube, Levine 1
- NAD Dressing, Wound, Occlusive 1
- ILI Sling, Arm 1
- KXG Applicator, Absorbent Tipped, Sterile 1
- NAB Gauze / Sponge,Nonresorbable For External Use 1
- GEN Forceps, General & Plastic Surgery 1
- JTW System, Transport, Aerobic 1
- KNX Collector, Urine, (And Accessories) For… 1
- FMH Container, Specimen, Sterile 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
| K802016 | Eye Applicators CAT.#980-983KXF · Traditional | 09/16/1980SE |
| K802013 | First Aid Bandage CAT.#198 or 199KGX · Traditional | 09/16/1980SE |
| K802010 | Guaze Swabs CAT.#251-300 (Size & Ply)EFQ · Traditional | 09/16/1980SE |
| K802006 | Triangular Bandage CAT.#191ILI · Traditional | 09/16/1980SE |
| K802005 | Absorbent Pad CAT.#729, 732, 730, 731EFQ · Traditional | 09/16/1980SE |
| K802004 | Profile Swab CAT.#5273 & 5274KXG · Traditional | 09/16/1980SE |
| K802001 | Lap Sponges CAT.#801-850KKX · Traditional | 09/16/1980SE |
| K801999 | Guaze Balls CAT.#601-720EFQ · Traditional | 09/16/1980SE |
| K801996 | Guaze Bandages CAT.#101-169NAB · Traditional | 09/16/1980SE |
| K801991 | Plastic Forceps CAT.#1001-1010GEN · Traditional | 09/16/1980SE |
| K802023 | Culswab CAT.#978 & 979JTW · Traditional | 09/09/1980SE |
| K802020 | Prep Set CAT.#908KXF · Traditional | 09/09/1980SE |
| K802015 | Finger Painguard CAT.#193-194FQM · Traditional | 09/09/1980SE |
| K802012 | Tribag, Urine Bag System #1109,& 1301-12KNX · Traditional | 09/09/1980SE |
| K802008 | Breaking Cast Wire CAT.#1112-1115 · Traditional | 09/09/1980SE |
| K802003 | Plastic Disposable Razor CAT.#1017,1018LDQ · Traditional | 09/09/1980SE |
| K802002 | Urine Specimen Container #'S 1013-1016FMH · Traditional | 09/09/1980SE |
| K801998 | Sterile Examination Glove #5121-5126FMC · Traditional | 09/09/1980SE |
| K801997 | Embossed Disp. Poly. Gloves #5101-03FMC · Traditional | 09/09/1980SE |
| K801995 | Eye Pads CAT.#581-599HMP · Traditional | 09/09/1980SE |
| K801990 | Elastic Bandage CAT.#182-186 (Width)FQM · Traditional | 09/09/1980SE |