Panels › General, Plastic Surgery › Product code GDY · Class 1
Gauze/Sponge, Internal, X-Ray Detectable
Regulation 878.4450
0510(k)s in 12 months (111 all time)
1recalls in 12 months (66 all time)
53recalls that name a 510(k)
Top companies in GDY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company | 0 | 36 |
| Lorrex Health Products | 9 | 0 |
| Argon Medical Devices, Inc | 0 | 7 |
| Medical Perspectives Corp. | 7 | 0 |
| Thantex Specialties, Inc. | 7 | 0 |
| Ultracell Medical Technologies, Inc. | 7 | 0 |
| Mcneil Healthcare, Inc. | 5 | 0 |
| Medical Action Industries, Inc. | 1 | 4 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 5 |
| Carefree Surgical Specialties | 0 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 1991 | K914082 | SUAN FLAT DISSECTOR SPONGES Icn Pharmaceuticals, Inc. | GDY |
| Nov 20, 1991 | K913794 | SIMPEX INC. SURGICAL DRESSING Simpex, Inc. | GDY |
| Oct 9, 1991 | K914083 | ICAN K DISSECTOR SPONGES Icn Pharmaceuticals, Inc. | GDY |
| Mar 6, 1991 | K905135 | LAPAROTOMY SPONGES American Healthcare Corp., CA | GDY |
| Nov 29, 1990 | K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE Advance Medical Designs, Inc. | GDY |
| Nov 3, 1989 | K895372 | X-RAY DETECTABLE GAUZE SPONGE Keilei Intl., Inc. | GDY |
| Sep 5, 1989 | K894984 | MASCOT LAB SPONGE Mascot, Inc. | GDY |
| Dec 9, 1988 | K884790 | QUALTEX NEUROLOK SURGICAL SPONGE Deroyal Industries, Inc. | GDY |
| Aug 3, 1988 | K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING Bioseal | GDY |
| Aug 3, 1988 | K882708 | GAUZE SPONGE, X-RAY DETECTABLE Bioseal | GDY |
| Aug 3, 1988 | K882707 | GAUZE PACKING, X-RAY DETECTABLE Bioseal | GDY |
| Sep 11, 1987 | K873391 | MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8 Ormed Mfg., Inc. | GDY |
| Aug 4, 1987 | K872809 | GAUZE CHERRY SPONGE American Silk Sutures, Inc. | GDY |
| Aug 4, 1987 | K872807 | NON-WOVEN TRACHEOTOMY SPONGE American Silk Sutures, Inc. | GDY |
| Dec 16, 1986 | K864529 | LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 Elof Hansson, Inc. | GDY |
| Oct 14, 1986 | K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 Lifestream Int'L, Inc. | GDY |
| Dec 17, 1985 | K854714 | X-RAY DETECTABLE COTTON BALLS American Silk Sutures, Inc. | GDY |
| Oct 8, 1985 | K853742 | GAUZE SPONGE South Mountain Medical | GDY |
| Aug 15, 1984 | K842572 | GAUZE & LAB SPONGES STERILE & NON Ulti-Med Intl., Inc. | GDY |
| Apr 23, 1984 | K840541 | NEURO SPONGE Surgicot, Inc. | GDY |
| Feb 17, 1984 | K833626 | FLORET FOAM PREP SPONGE Ritmed, Inc. | GDY |
| Oct 31, 1983 | K831914 | STRUNG NEURO SPONGE PATTIES-X-RAY- Ormed Mfg., Inc. | GDY |
| Sep 26, 1983 | K831913 | COLOR-EZE PRE-WASHED LAP SPONGES Ormed Mfg., Inc. | GDY |
| Aug 12, 1983 | K832172 | GAUZE SPONGE X-RAY DETECTABLE- Sudreca Surgical Dressings, Inc. | GDY |
| Mar 17, 1983 | K830511 | ZANLEX, ZAN-TEX & ZANDEX Winn Hirsch & Assoc. | GDY |
| Mar 17, 1983 | K830260 | FLORET VAGINAL PACKING/TAMPONS Ritmed, Inc. | GDY |
| Feb 23, 1983 | K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON American Medical Disposable, Inc. | GDY |
| Feb 23, 1983 | K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE American Medical Disposable, Inc. | GDY |
| Jan 9, 1983 | K823671 | NO-GAUZE LAPAROTOMY SPONGE Surgilite Intl., Inc. | GDY |
| Oct 13, 1982 | K822623 | LAPAROTOMY SPONGE Hermitage Hospital Products, Inc. | GDY |
| Jan 22, 1982 | K813286 | PRE-PACK TENS Cunningham Woodland, Inc. | GDY |
| Jan 18, 1982 | K813595 | PARKE-DAVIS AEGIS ABOSRBENT SPONGES Deseret Medical, Inc. | GDY |
| Nov 24, 1981 | K812391 | NEUROSPONGES Winn Hirsch & Assoc. | GDY |
| Nov 24, 1981 | K812390 | NEUROSPONGE PADDIE Winn Hirsch & Assoc. | GDY |
| Nov 20, 1981 | K812018 | X-RAY DETECTABLE THREAD Isramed, Inc. | GDY |
| Nov 20, 1981 | K812017 | X-RAY DETECTABLE BAND Isramed, Inc. | GDY |
| Nov 6, 1981 | K812831 | SURGICAL DRESSINGS Foreign Trade Zone of Wisconsin | GDY |
| Nov 2, 1981 | K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT Medspec Corp. | GDY |
| Nov 2, 1981 | K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT Medspec Corp. | GDY |
| Oct 20, 1981 | K812651 | X-RAY DETECTABLE LAP SPONGES Procter & Gamble Mfg. Co. | GDY |
| Sep 24, 1981 | K812554 | TOMAC STERILE DISP. LAP SPONGE American Convertors Div., American Pharmaseal | GDY |
| Sep 11, 1981 | K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) Robert I. Chien & Assoc., Inc. | GDY |
| Aug 7, 1981 | K811769 | LAPAROTOMY PADS South Mountain Medical | GDY |
| Feb 4, 1981 | K810184 | LAPAROTOMY SPONGE Medical Action Industries, Inc. | GDY |
| Jan 15, 1981 | K803188 | GAUZE SPONGES Abco Dealers, Inc. | GDY |
| Dec 19, 1980 | K802982 | GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. Stanford Laboratories | GDY |
| Dec 11, 1980 | K802798 | OPRATEX ABDOMINAL PAD Secol Co. | GDY |
| Oct 10, 1980 | K802060 | STERILE TONSIL SPONGES Medspec Corp. | GDY |
| Aug 20, 1980 | K801768 | CONTAIN X-RAY DETECTABLE LAP SPONGE The Buckeye Cellulose Corp. | GDY |
| Mar 12, 1980 | K800281 | MEDSPEC PACKING GAUZE Medspec Corp. | GDY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.