FDA Product Code
FDA Product Code KGX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5240
510(k) Clearances — 187 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001240 | SERAGARD INJECTION PATCH | Platinum Services, Inc. | 2000-06-21 | Traditional | PDF ↗ |
| K983368 | CARE BAND ANTIBACTERIAL BANDAGES | Aso Corp. | 1999-02-17 | Traditional | PDF ↗ |
| K972914 | SYVEK PATCH | Marine Polymer Technologies, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K952606 | TARGETT PATCH | Cutting Edge Technologies, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K954007 | PARALLEL | Johnson & Johnson Consumer Products, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K944587 | DERMIVIEW HYPOALLERGENIC CLEAR TAPE | Johnson & Johnson Medical, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K944588 | STERILE PLASTIC DRESSING | Smith & Nephew, Inc. | 1994-11-07 | Traditional | PDF ↗ |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K940798 | SHIPPERT PRESSURE BANDAGE | Denver Splint Co. | 1994-09-28 | Traditional | PDF ↗ |
| K941389 | EMPI TAPE PATCHES | Empi | 1994-08-23 | Traditional | PDF ↗ |
| K942383 | DERMIVIEW CLEAR TAPE | Johnson & Johnson International | 1994-08-22 | Traditional | PDF ↗ |
| K940378 | COVERLET ADHESIVE DRESSING | Beiersdorf, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Kit Pak, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K941943 | SURGICAL ADHESIVE TAPE | Raleigh Lions Clinic For the Blind, Inc. | 1994-06-30 | Traditional | PDF ↗ |
| K941379 | ACE SPORTS TAPE | Becton Dickinson Consumer Products | 1994-06-13 | Traditional | PDF ↗ |
| K935948 | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM | Convatec, A Division of E.R. Squibb & Sons | 1994-03-01 | Traditional | PDF ↗ |
| K932457 | SPYROGEL WOUND DRESSING | Polymint Industrial Co. , Ltd. | 1994-02-09 | Traditional | PDF ↗ |
| K935725 | EPISEAL ADHESIVE WOUND CLOSURE STRIPS | Deroyal Industries, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K930457 | MEDIMAC BANDAGE | Enquay Pharmaceutical | 1994-01-25 | Traditional | PDF ↗ |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | 3M Health Care, Ltd. | 1993-12-27 | Traditional | PDF ↗ |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | Scott Health Care | 1993-09-10 | Traditional | PDF ↗ |
| K931886 | TISSUE ISOLATION AND RETRIEVAL BAG | Advanced Surgical, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K924192 | I.V. START KIT (AHC-50-54954 | American Healthcare Corp. | 1993-08-27 | Traditional | PDF ↗ |
| K922441 | SURESEAL BANDAGE | Gainor Medical Europe, Ltd. | 1993-08-10 | Traditional | PDF ↗ |
| K932602 | ADHESIVE BANDAGES | Aso Corp. | 1993-08-09 | Traditional | PDF ↗ |
| K924794 | TRANSPARENT ADHESIVE DRESSING | Medical Concepts Development, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K923319 | SHAWNEE PRODUCT KIT IV | Absentee Shawnee Bandage Group | 1993-06-17 | Traditional | PDF ↗ |
| K923235 | BIOCLUSIVE MVP TRANSPARENT DRESSING | Johnson & Johnson Medical, Inc. | 1993-05-12 | Traditional | PDF ↗ |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | Lectec Corp. | 1993-04-21 | Traditional | PDF ↗ |
| K926264 | MEDICOTEST SKIN FIX | Medicotest, Inc. | 1993-04-20 | Traditional | PDF ↗ |
| K923662 | INGROWN TOENAIL PAD | Many Bee Co. | 1993-04-20 | Traditional | PDF ↗ |
| K921761 | SHAWNEE PRODUCTS KIT II | Absentee Shawnee Bandage Group | 1993-03-18 | Traditional | PDF ↗ |
| K923358 | LC STRIP | Genetic Laboratories Wound Care, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | Spenco Medical Corp. | 1992-12-11 | Traditional | PDF ↗ |
| K923400 | DERMCO A-I | Dermaco, Inc. | 1992-10-06 | Traditional | PDF ↗ |
| K922897 | STRAPPAL | Smith & Nephew United, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K922959 | ISOPORE TAPE | Lectec Corp. | 1992-09-11 | Traditional | PDF ↗ |
| K923404 | LUEKOFLEX SURGICAL TAPE | Beiersdorf, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K923300 | DEROYAL EYE DRESSING | Deroyal Industries, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K920675 | DUODERM SUSTAINED COMPRESSION BANDAGE | Convatec, A Division of E.R. Squibb & Sons | 1992-08-18 | Traditional | PDF ↗ |
| K921760 | TRICOPLAST | Beiersdorf, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K921759 | ACRYLASTIC | Beiersdorf, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K914733 | TTL MEDICATED DRESSING | Medimix Products, Inc. | 1992-07-01 | Traditional | PDF ↗ |
| K915446 | STRETCH WRAP | Sun Glitz Corp. | 1992-05-06 | Traditional | PDF ↗ |
| K915358 | PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH | Medtronic Vascular | 1992-04-28 | Traditional | PDF ↗ |
| K920182 | MARION WINDOW | Tnt Moberg Intl. , Ltd. | 1992-03-26 | Traditional | PDF ↗ |
| K915057 | CANN-HOLD | O.R. Concepts, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K914596 | SURGICAL CLOTH TAPE (HEALRITE) | Industrias Tuk, S.A. DE C.V. | 1992-03-19 | Traditional | PDF ↗ |
| K914597 | SURGICAL MICROPOROUS TAPE (MICROCEL) | Industrias Tuk, S.A. DE C.V. | 1992-03-19 | Traditional | PDF ↗ |
| K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION | Medical Dynamics, Inc. | 1992-03-04 | Traditional | PDF ↗ |
| K915565 | IMMOBILE | Tnt Moborg Intl. , Ltd. | 1992-03-02 | Traditional | PDF ↗ |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | Dale Medical Products, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K914912 | PROMEON 63B SURGICAL TAPE | Promeon | 1991-12-04 | Traditional | PDF ↗ |
| K912623 | MEDICAL TAPE | Renfrew Tape, Ltd. | 1991-11-27 | Traditional | PDF ↗ |
| K912160 | BUTTERFLY DRESSING | Durden Enterprises, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K912518 | CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE | Convatec, A Division of E.R. Squibb & Sons | 1991-09-04 | Traditional | PDF ↗ |
| K912550 | DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED | Convatec, A Division of E.R. Squibb & Sons | 1991-08-14 | Traditional | PDF ↗ |
| K912520 | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX | 3M Health Care, Ltd. | 1991-07-26 | Traditional | PDF ↗ |
| K911682 | AIRSTRIP FIRST AID & POST-OP DRESSING | Smith & Nephew United, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K910657 | QUALTEX ISLAND DRESSING | Deroyal Industries, Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K895920 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS | Vitaphore Corp. | 1991-06-06 | Traditional | PDF ↗ |
| K910678 | TRO-GARD | Conmedcorp | 1991-05-08 | Traditional | PDF ↗ |
| K904904 | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION | Graham-Field, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K910436 | ELASTIC ADHESIVE BANDAGE | Byron Medical | 1991-03-19 | Traditional | PDF ↗ |
| K904445 | OMIBAND | Omikron Scientific, Ltd. | 1991-03-06 | Traditional | PDF ↗ |
| K905022 | AQUA-GARD WATERPROOF WOUND PATCH | Bellhouse Medical, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K903823 | SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE | Smith and Nephew Donjoy, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K904500 | ELASTOPLAST | Beiersdorf, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K896068 | TIPSTOP(TM) | Gambro-Hospal, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K901777 | 3M FIRST AID BANDAGE FOR MINOR WOUNDS | 3M Company | 1990-08-08 | Traditional | PDF ↗ |
| K901845 | TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX | 3M Company | 1990-07-23 | Traditional | PDF ↗ |
| K901879 | INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) | Smith & Nephew United, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K902010 | VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE | Visitec Co. | 1990-06-20 | Traditional | PDF ↗ |
| K900447 | DUODERM* ADHESIVE COMPRESSION BANDAGE | Convatec, A Division of E.R. Squibb & Sons | 1990-04-13 | Traditional | PDF ↗ |
| K896455 | VITACHOICE WOUND DRESSING | Vitaphore Corp. | 1990-02-15 | Traditional | PDF ↗ |
| K896891 | LEUKOSILK(TM) SURGICAL TAPE | Beiersdorf, Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K896733 | VACCON | Unoplast A/S | 1990-02-01 | Traditional | PDF ↗ |
| K896358 | VARI/MOIST WOUND DRESSING | Catalina Biomedical Corp. | 1990-02-01 | Traditional | PDF ↗ |
| K895884 | BANDAGE REMOVAL STRIP | Kut-Guard, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K895408 | OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) | Smith & Nephew United, Inc. | 1989-12-14 | Traditional | PDF ↗ |
| K894367 | LEUKOSPORT(TM) ADHESIVE TAPE | Beiersdorf, Inc. | 1989-11-15 | Traditional | PDF ↗ |
| K892450 | MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS | Quinton, Inc. | 1989-10-11 | Traditional | PDF ↗ |
| K895353 | OPSITE I.V. 3000 | Smith & Nephew United, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K894916 | COMFEEL TRANSPARENT DRESSING | Coloplast A/S | 1989-09-26 | Traditional | PDF ↗ |
| K893569 | QUICK CHANGE MONTGOMERY STRAP | Med-Dex Intl. | 1989-09-25 | Traditional | PDF ↗ |
| K895376 | ACTIDERM (TM) DERMATOLOGICAL PATCH | Convatec, A Division of E.R. Squibb & Sons | 1989-09-25 | Traditional | PDF ↗ |
| K894274 | EXUSORB TRANSPARENT DRESSING | Controlled Therapeutics Corp. | 1989-08-18 | Traditional | PDF ↗ |
| K890917 | PHOENIX DRAPES WITH MICROBAN | Phoenix Medical Technology, Inc. | 1989-08-17 | Traditional | PDF ↗ |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | James River Corp. | 1989-08-09 | Traditional | PDF ↗ |
| K893900 | PRIMAPORE I.V. | Smith & Nephew United, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K885205 | AQUADERM | Laivan Corp. | 1989-03-29 | Traditional | PDF ↗ |
| K883660 | DERMASTRIP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-02-08 | Traditional | PDF ↗ |
| K883983 | SANIFIX | Iberhospitex, S.A. | 1988-12-13 | Traditional | PDF ↗ |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | Lectec Corp. | 1988-11-10 | Traditional | PDF ↗ |
| K881397 | SANAPLAST | Nebo Industries | 1988-06-14 | Traditional | PDF ↗ |
| K881509 | LEUKOPOR(TM) SURGICAL TAPE | Beiersdorf, Inc. | 1988-04-22 | Traditional | PDF ↗ |
| K880207 | EXPANDOVER ELASTIC BANDAGE | Expandover C/O Hale and Dorr | 1988-04-21 | Traditional | PDF ↗ |
| K880964 | POLYDERM PEC(TM), POROUS ELASTIC COVER | Laivan Corp. | 1988-03-17 | Traditional | PDF ↗ |
Product code KGX · Class I · General Hospital. Data: openFDA.