Panels › Gastroenterology, Urology › Product code KDH · Class 2
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Regulation 876.5980
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KDH
| Company | 510(k)s | Recalls |
|---|---|---|
| Autovage | 4 | 0 |
| Ethox Corp. | 2 | 0 |
| Sherwood Medical Industries | 2 | 0 |
| Tri-Med Specialties, Inc. | 2 | 0 |
| Armm, Inc. | 1 | 0 |
| Axiom Medical, Inc. | 1 | 0 |
| B.Braun Medical, Inc. | 1 | 0 |
| Ballard Medical Products | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Biomedical Dynamics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 1999 | K983624 | GILTECH PLUS CONNECTING TUBE SET Giltech Plus, Inc. | KDH |
| Jun 19, 1998 | K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS Armm, Inc. | KDH |
| Oct 27, 1997 | K971259 | COMBIPORT FLUID LAVAGE DEVICE B.Braun Medical, Inc. | KDH |
| Feb 21, 1997 | K962850 | TUM-E-VAC Ethox Corp. | KDH |
| Jul 5, 1995 | K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT Ballard Medical Products | KDH |
| Mar 21, 1994 | K923497 | FLUSHING IRRIGATION SET Orion Life Systems, Inc. | KDH |
| Sep 4, 1992 | K920619 | TRI-MED GASTRIC LAVAGE SYSTEM Tri-Med Specialties, Inc. | KDH |
| Sep 4, 1992 | K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT Tri-Med Specialties, Inc. | KDH |
| Apr 13, 1992 | K914908 | QUICVAGE PLUS Autovage | KDH |
| Jan 24, 1992 | K914907 | QUICVAGE Autovage | KDH |
| Jul 26, 1991 | K911919 | MINIVAGE(R) Autovage | KDH |
| Jul 26, 1991 | K911788 | ECONOVAGE R Autovage | KDH |
| Jun 24, 1991 | K911324 | IRRIGATION/ASPIRATION TUBING SET Biomedical Dynamics, Inc. | KDH |
| Nov 20, 1990 | K902421 | STOMACH, GASTRO-ENTEROSTOMY Gainor Medical Europe, Ltd. | KDH |
| Mar 19, 1990 | K900086 | HEMORRHOIDAL LIGATOR WITH SUCTION Baxter Healthcare Corp | KDH |
| Jan 29, 1990 | K896573 | EASI-LAV ADULT GASTRIC LAVAGE KIT Clairson Industries, LLC | KDH |
| May 31, 1989 | K892334 | LEONARD TUBE Surgidyne, Inc. | KDH |
| Mar 11, 1986 | K860599 | ETHOX LAVAGE TUBE Ethox Corp. | KDH |
| Jun 22, 1982 | K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM Innovative Surgical Products, Inc. | KDH |
| Dec 4, 1978 | K781749 | TUBING, AXIOM SILICONE PENROSE Axiom Medical, Inc. | KDH |
| Apr 21, 1978 | K770534 | THERAPEUTIC APPARATUS, DIERKER TYPE Well Being Ent. | KDH |
| Mar 9, 1977 | K770248 | ARGYLE RAPID GASTRIC LAVAGE KIT Sherwood Medical Industries | KDH |
| Feb 17, 1977 | K760556 | IRRIGATION CATHETER Sherwood Medical Industries | KDH |
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