Panels › General Hospital › Product code KGX · Class 1
Tape And Bandage, Adhesive
Regulation 880.5240
0510(k)s in 12 months (187 all time)
9recalls in 12 months (48 all time)
2recalls that name a 510(k)
Top companies in KGX
| Company | 510(k)s | Recalls |
|---|---|---|
| Beiersdorf, Inc. | 15 | 0 |
| 3M Company / Medical Division | 0 | 8 |
| Breg Inc | 0 | 8 |
| Lectec Corp. | 8 | 0 |
| Medline Industries, LP | 0 | 7 |
| 3M Company | 6 | 0 |
| Avery Intl. | 6 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 6 | 0 |
| Johnson & Johnson Professionals, Inc. | 6 | 0 |
| Smith & Nephew United, Inc. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 1992 | K914596 | SURGICAL CLOTH TAPE (HEALRITE) Industrias Tuk, S.A. DE C.V., MX | KGX |
| Mar 4, 1992 | K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION Medical Dynamics, Inc. | KGX |
| Mar 2, 1992 | K915565 | IMMOBILE Tnt Moborg Intl. , Ltd. | KGX |
| Dec 9, 1991 | K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) Dale Medical Products, Inc. | KGX |
| Dec 4, 1991 | K914912 | PROMEON 63B SURGICAL TAPE Promeon | KGX |
| Nov 27, 1991 | K912623 | MEDICAL TAPE Renfrew Tape, Ltd., CA | KGX |
| Oct 9, 1991 | K912160 | BUTTERFLY DRESSING Durden Enterprises, Inc. | KGX |
| Sep 4, 1991 | K912518 | CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons | KGX |
| Aug 14, 1991 | K912550 | DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED Convatec, A Division of E.R. Squibb & Sons | KGX |
| Jul 26, 1991 | K912520 | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX 3M Health Care, Ltd. | KGX |
| Jul 17, 1991 | K911682 | AIRSTRIP FIRST AID & POST-OP DRESSING Smith & Nephew United, Inc. | KGX |
| Jul 1, 1991 | K910657 | QUALTEX ISLAND DRESSING Deroyal Industries, Inc. | KGX |
| Jun 6, 1991 | K895920 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS Vitaphore Corp. | KGX |
| May 8, 1991 | K910678 | TRO-GARD Conmedcorp | KGX |
| Mar 19, 1991 | K910436 | ELASTIC ADHESIVE BANDAGE Byron Medical | KGX |
| Mar 19, 1991 | K904904 | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION Graham-Field, Inc. | KGX |
| Mar 6, 1991 | K904445 | OMIBAND Omikron Scientific, Ltd., IL | KGX |
| Feb 11, 1991 | K905022 | AQUA-GARD WATERPROOF WOUND PATCH Bellhouse Medical, Inc. | KGX |
| Jan 16, 1991 | K903823 | SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE Smith and Nephew Donjoy, Inc. | KGX |
| Nov 21, 1990 | K904500 | ELASTOPLAST Beiersdorf, Inc. | KGX |
| Sep 10, 1990 | K896068 | TIPSTOP(TM) Gambro-Hospal, Inc. | KGX |
| Aug 8, 1990 | K901777 | 3M FIRST AID BANDAGE FOR MINOR WOUNDS 3M Company | KGX |
| Jul 23, 1990 | K901845 | TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX 3M Company | KGX |
| Jun 22, 1990 | K901879 | INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) Smith & Nephew United, Inc. | KGX |
| Jun 20, 1990 | K902010 | VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE Visitec Co. | KGX |
| Apr 13, 1990 | K900447 | DUODERM* ADHESIVE COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons | KGX |
| Feb 15, 1990 | K896455 | VITACHOICE WOUND DRESSING Vitaphore Corp. | KGX |
| Feb 9, 1990 | K896891 | LEUKOSILK(TM) SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Feb 1, 1990 | K896733 | VACCON Unoplast A/S, DK | KGX |
| Feb 1, 1990 | K896358 | VARI/MOIST WOUND DRESSING Catalina Biomedical Corp. | KGX |
| Dec 27, 1989 | K895884 | BANDAGE REMOVAL STRIP Kut-Guard, Inc. | KGX |
| Dec 14, 1989 | K895408 | OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) Smith & Nephew United, Inc. | KGX |
| Nov 15, 1989 | K894367 | LEUKOSPORT(TM) ADHESIVE TAPE Beiersdorf, Inc. | KGX |
| Oct 11, 1989 | K892450 | MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS Quinton, Inc. | KGX |
| Sep 28, 1989 | K895353 | OPSITE I.V. 3000 Smith & Nephew United, Inc. | KGX |
| Sep 26, 1989 | K894916 | COMFEEL TRANSPARENT DRESSING Coloplast A/S | KGX |
| Sep 25, 1989 | K895376 | ACTIDERM (TM) DERMATOLOGICAL PATCH Convatec, A Division of E.R. Squibb & Sons | KGX |
| Sep 25, 1989 | K893569 | QUICK CHANGE MONTGOMERY STRAP Med-Dex Intl. | KGX |
| Aug 18, 1989 | K894274 | EXUSORB TRANSPARENT DRESSING Controlled Therapeutics Corp. | KGX |
| Aug 17, 1989 | K890917 | PHOENIX DRAPES WITH MICROBAN Phoenix Medical Technology, Inc. | KGX |
| Aug 9, 1989 | K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING James River Corp. | KGX |
| Aug 3, 1989 | K893900 | PRIMAPORE I.V. Smith & Nephew United, Inc. | KGX |
| Mar 29, 1989 | K885205 | AQUADERM Laivan Corp. | KGX |
| Feb 8, 1989 | K883660 | DERMASTRIP Bd Becton Dickinson Vacutainer Systems Preanalytic | KGX |
| Dec 13, 1988 | K883983 | SANIFIX Iberhospitex, S.A., ES | KGX |
| Nov 10, 1988 | K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE Lectec Corp. | KGX |
| Jun 14, 1988 | K881397 | SANAPLAST Nebo Industries | KGX |
| Apr 22, 1988 | K881509 | LEUKOPOR(TM) SURGICAL TAPE Beiersdorf, Inc. | KGX |
| Apr 21, 1988 | K880207 | EXPANDOVER ELASTIC BANDAGE Expandover C/O Hale and Dorr | KGX |
| Mar 17, 1988 | K880964 | POLYDERM PEC(TM), POROUS ELASTIC COVER Laivan Corp. | KGX |
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