Company ยท US
Pollak (Intl.), Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2000. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 |
| FMC | Patient Examination Glove | 2 |
| FQM | Bandage, Elastic | 2 |
| KDD | Kit, Surgical Instrument, Disposable | 2 |
| KGX | Tape And Bandage, Adhesive | 2 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 2 |
| FKK | Clamp, Line | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 |
| FMH | Container, Specimen, Sterile | 1 |
| FRQ | Tube, Levine | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| HFW | Clamp, Umbilical | 1 |
| HMP | Pad, Eye | 1 |
| ILI | Sling, Arm | 1 |
| JTW | System, Transport, Aerobic | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KMJ | Lubricant, Patient | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| KXG | Applicator, Absorbent Tipped, Sterile | 1 |
| LDQ | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2000 | K000227 | UMBICUT Pollak (Intl.), Ltd., IL | HFW |
| Apr 21, 1981 | K810049 | PEDICAT* Pollak (Intl.), Ltd. | KMJ |
| Mar 26, 1981 | K810050 | VECAFIX* Pollak (Intl.), Ltd. | KGX |
| Oct 31, 1980 | K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 Pollak (Intl.), Ltd. | FLN |
| Oct 31, 1980 | K802009 | FLOWCLAMP CAT.#1011 & 1012 Pollak (Intl.), Ltd. | FKK |
| Oct 10, 1980 | K802017 | DRESSING CHANGE SET CAT.#910-930 Pollak (Intl.), Ltd. | KDD |
| Sep 26, 1980 | K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL Pollak (Intl.), Ltd. | FRQ |
| Sep 16, 1980 | K802022 | STERILE GUAZE SWABS CAT.#301-420 Pollak (Intl.), Ltd. | EFQ |
| Sep 16, 1980 | K802021 | PEDIBAND CAT.#195-197 Pollak (Intl.), Ltd. | NAD |
| Sep 16, 1980 | K802019 | SUTURE REMOVAL SET CAT.#906 Pollak (Intl.), Ltd. | KDD |
| Sep 16, 1980 | K802016 | EYE APPLICATORS CAT.#980-983 Pollak (Intl.), Ltd. | KXF |
| Sep 16, 1980 | K802013 | FIRST AID BANDAGE CAT.#198 OR 199 Pollak (Intl.), Ltd. | KGX |
| Sep 16, 1980 | K802010 | GUAZE SWABS CAT.#251-300 (SIZE & PLY) Pollak (Intl.), Ltd. | EFQ |
| Sep 16, 1980 | K802006 | TRIANGULAR BANDAGE CAT.#191 Pollak (Intl.), Ltd. | ILI |
| Sep 16, 1980 | K802005 | ABSORBENT PAD CAT.#729, 732, 730, 731 Pollak (Intl.), Ltd. | EFQ |
| Sep 16, 1980 | K802004 | PROFILE SWAB CAT.#5273 & 5274 Pollak (Intl.), Ltd. | KXG |
| Sep 16, 1980 | K802001 | LAP SPONGES CAT.#801-850 Pollak (Intl.), Ltd. | KKX |
| Sep 16, 1980 | K801999 | GUAZE BALLS CAT.#601-720 Pollak (Intl.), Ltd. | EFQ |
| Sep 16, 1980 | K801996 | GUAZE BANDAGES CAT.#101-169 Pollak (Intl.), Ltd. | NAB |
| Sep 16, 1980 | K801991 | PLASTIC FORCEPS CAT.#1001-1010 Pollak (Intl.), Ltd. | GEN |
| Sep 9, 1980 | K802023 | CULSWAB CAT.#978 & 979 Pollak (Intl.), Ltd. | JTW |
| Sep 9, 1980 | K802020 | PREP SET CAT.#908 Pollak (Intl.), Ltd. | KXF |
| Sep 9, 1980 | K802015 | FINGER PAINGUARD CAT.#193-194 Pollak (Intl.), Ltd. | FQM |
| Sep 9, 1980 | K802012 | TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 Pollak (Intl.), Ltd. | KNX |
| Sep 9, 1980 | K802008 | BREAKING CAST WIRE CAT.#1112-1115 Pollak (Intl.), Ltd. | |
| Sep 9, 1980 | K802003 | PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 Pollak (Intl.), Ltd. | LDQ |
| Sep 9, 1980 | K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 Pollak (Intl.), Ltd. | FMH |
| Sep 9, 1980 | K801998 | STERILE EXAMINATION GLOVE #5121-5126 Pollak (Intl.), Ltd. | FMC |
| Sep 9, 1980 | K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 Pollak (Intl.), Ltd. | FMC |
| Sep 9, 1980 | K801995 | EYE PADS CAT.#581-599 Pollak (Intl.), Ltd. | HMP |
| Sep 9, 1980 | K801990 | ELASTIC BANDAGE CAT.#182-186 (WIDTH) Pollak (Intl.), Ltd. | FQM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||