Atlas FDA

KGX

187 FDA 510(k) clearances · Product code

84 daysmedian time to decision
254 days90th percentile
187clearances measured

FDA profile

Official device name
Tape And Bandage, Adhesive
Device class
Class I (low risk)
Regulation
21 CFR 880.5240
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 562 · 2022: 253 · 2023: 192 · 2024: 224 · 2025: 323 · 2026: 297
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SERAGARD INJECTION PATCH (K001240)Platinum Services, Inc.2000-06-21
CARE BAND ANTIBACTERIAL BANDAGES (K983368)Aso Corp.1999-02-17
SYVEK PATCH (K972914)Marine Polymer Technologies, Inc.1997-12-22
ADHESIVE BANDAGES WITH OTC DRUG (K943314)Johnson & Johnson Consumer Products, Inc.1996-01-17
TARGETT PATCH (K952606)Cutting Edge Technologies, Inc.1995-12-21
PARALLEL (K954007)Johnson & Johnson Consumer Products, Inc.1995-11-22
DERMIVIEW HYPOALLERGENIC CLEAR TAPE (K944587)Johnson & Johnson Medical, Inc.1995-10-30
STERILE PLASTIC DRESSING (K944588)Smith & Nephew, Inc.1994-11-07
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (K941788)Johnson & Johnson Consumer Products, Inc.1994-10-03
BAND-AID(TM) BRAND ADHESIVE BANDAGE (K940536)Johnson & Johnson Consumer Products, Inc.1994-10-03
SHIPPERT PRESSURE BANDAGE (K940798)Denver Splint Co.1994-09-28
EMPI TAPE PATCHES (K941389)Empi1994-08-23
DERMIVIEW CLEAR TAPE (K942383)Johnson & Johnson International1994-08-22
COVERLET ADHESIVE DRESSING (K940378)Beiersdorf, Inc.1994-07-29
KIT PAK DRESSING CHANGE TRAY (K941499)Kit Pak, Inc.1994-07-20
SURGICAL ADHESIVE TAPE (K941943)Raleigh Lions Clinic For the Blind, Inc.1994-06-30
ACE SPORTS TAPE (K941379)Becton Dickinson Consumer Products1994-06-13
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM (K935948)Convatec, A Division of E.R. Squibb & Sons1994-03-01
SPYROGEL WOUND DRESSING (K932457)Polymint Industrial Co. , Ltd.1994-02-09
EPISEAL ADHESIVE WOUND CLOSURE STRIPS (K935725)Deroyal Industries, Inc.1994-02-04
MEDIMAC BANDAGE (K930457)Enquay Pharmaceutical1994-01-25
3M TEGADERM HP TRANSPARENT DRESSING (K932422)3M Health Care, Ltd.1993-12-27
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION (K932743)Scott Health Care1993-09-10
TISSUE ISOLATION AND RETRIEVAL BAG (K931886)Advanced Surgical, Inc.1993-09-07
I.V. START KIT (AHC-50-54954 (K924192)American Healthcare Corp.1993-08-27
SURESEAL BANDAGE (K922441)Gainor Medical Europe, Ltd.1993-08-10
ADHESIVE BANDAGES (K932602)Aso Corp.1993-08-09
TRANSPARENT ADHESIVE DRESSING (K924794)Medical Concepts Development, Inc.1993-07-08
SHAWNEE PRODUCT KIT IV (K923319)Absentee Shawnee Bandage Group1993-06-17
BIOCLUSIVE MVP TRANSPARENT DRESSING (K923235)Johnson & Johnson Medical, Inc.1993-05-12
ISOPORE(TM) TAPE, MODIFICATION (K925384)Lectec Corp.1993-04-21
MEDICOTEST SKIN FIX (K926264)Medicotest, Inc.1993-04-20
INGROWN TOENAIL PAD (K923662)Many Bee Co.1993-04-20
SHAWNEE PRODUCTS KIT II (K921761)Absentee Shawnee Bandage Group1993-03-18
LC STRIP (K923358)Genetic Laboratories Wound Care, Inc.1993-01-13
2ND SKIN STERILE ADHESIVE STRIP (K922228)Spenco Medical Corp.1992-12-11
DERMCO A-I (K923400)Dermaco, Inc.1992-10-06
STRAPPAL (K922897)Smith & Nephew United, Inc.1992-09-15
ISOPORE TAPE (K922959)Lectec Corp.1992-09-11
LUEKOFLEX SURGICAL TAPE (K923404)Beiersdorf, Inc.1992-09-09
DEROYAL EYE DRESSING (K923300)Deroyal Industries, Inc.1992-09-01
DUODERM SUSTAINED COMPRESSION BANDAGE (K920675)Convatec, A Division of E.R. Squibb & Sons1992-08-18
ACRYLASTIC (K921759)Beiersdorf, Inc.1992-08-10
TRICOPLAST (K921760)Beiersdorf, Inc.1992-08-10
TTL MEDICATED DRESSING (K914733)Medimix Products, Inc.1992-07-01
STRETCH WRAP (K915446)Sun Glitz Corp.1992-05-06
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH (K915358)Medtronic Vascular1992-04-28
MARION WINDOW (K920182)Tnt Moberg Intl. , Ltd.1992-03-26
SURGICAL CLOTH TAPE (HEALRITE) (K914596)Industrias Tuk, S.A. DE C.V.1992-03-19
CANN-HOLD (K915057)O.R. Concepts, Inc.1992-03-19
SURGICAL MICROPOROUS TAPE (MICROCEL) (K914597)Industrias Tuk, S.A. DE C.V.1992-03-19
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION (K914315)Medical Dynamics, Inc.1992-03-04
IMMOBILE (K915565)Tnt Moborg Intl. , Ltd.1992-03-02
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) (K914245)Dale Medical Products, Inc.1991-12-09
PROMEON 63B SURGICAL TAPE (K914912)Promeon1991-12-04
MEDICAL TAPE (K912623)Renfrew Tape, Ltd.1991-11-27
BUTTERFLY DRESSING (K912160)Durden Enterprises, Inc.1991-10-09
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE (K912518)Convatec, A Division of E.R. Squibb & Sons1991-09-04
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED (K912550)Convatec, A Division of E.R. Squibb & Sons1991-08-14
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX (K912520)3M Health Care, Ltd.1991-07-26
AIRSTRIP FIRST AID & POST-OP DRESSING (K911682)Smith & Nephew United, Inc.1991-07-17
QUALTEX ISLAND DRESSING (K910657)Deroyal Industries, Inc.1991-07-01
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (K895920)Vitaphore Corp.1991-06-06
TRO-GARD (K910678)Conmedcorp1991-05-08
ELASTIC ADHESIVE BANDAGE (K910436)Byron Medical1991-03-19
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION (K904904)Graham-Field, Inc.1991-03-19
OMIBAND (K904445)Omikron Scientific, Ltd.1991-03-06
AQUA-GARD WATERPROOF WOUND PATCH (K905022)Bellhouse Medical, Inc.1991-02-11
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE (K903823)Smith and Nephew Donjoy, Inc.1991-01-16
ELASTOPLAST (K904500)Beiersdorf, Inc.1990-11-21
TIPSTOP(TM) (K896068)Gambro-Hospal, Inc.1990-09-10
3M FIRST AID BANDAGE FOR MINOR WOUNDS (K901777)3M Company1990-08-08
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX (K901845)3M Company1990-07-23
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) (K901879)Smith & Nephew United, Inc.1990-06-22
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE (K902010)Visitec Co.1990-06-20
DUODERM* ADHESIVE COMPRESSION BANDAGE (K900447)Convatec, A Division of E.R. Squibb & Sons1990-04-13
VITACHOICE WOUND DRESSING (K896455)Vitaphore Corp.1990-02-15
LEUKOSILK(TM) SURGICAL TAPE (K896891)Beiersdorf, Inc.1990-02-09
VARI/MOIST WOUND DRESSING (K896358)Catalina Biomedical Corp.1990-02-01
VACCON (K896733)Unoplast A/S1990-02-01
BANDAGE REMOVAL STRIP (K895884)Kut-Guard, Inc.1989-12-27
OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) (K895408)Smith & Nephew United, Inc.1989-12-14
LEUKOSPORT(TM) ADHESIVE TAPE (K894367)Beiersdorf, Inc.1989-11-15
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS (K892450)Quinton, Inc.1989-10-11
OPSITE I.V. 3000 (K895353)Smith & Nephew United, Inc.1989-09-28
COMFEEL TRANSPARENT DRESSING (K894916)Coloplast A/S1989-09-26
ACTIDERM (TM) DERMATOLOGICAL PATCH (K895376)Convatec, A Division of E.R. Squibb & Sons1989-09-25
QUICK CHANGE MONTGOMERY STRAP (K893569)Med-Dex Intl.1989-09-25
EXUSORB TRANSPARENT DRESSING (K894274)Controlled Therapeutics Corp.1989-08-18
PHOENIX DRAPES WITH MICROBAN (K890917)Phoenix Medical Technology, Inc.1989-08-17
VISULIN TRANSPARENT ADHESIVE DRESSING (K894147)James River Corp.1989-08-09
PRIMAPORE I.V. (K893900)Smith & Nephew United, Inc.1989-08-03
AQUADERM (K885205)Laivan Corp.1989-03-29
DERMASTRIP (K883660)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-08
SANIFIX (K883983)Iberhospitex, S.A.1988-12-13
MACROPORE MEDICAL/SURGICAL PAPER TAPE (K884108)Lectec Corp.1988-11-10
SANAPLAST (K881397)Nebo Industries1988-06-14
LEUKOPOR(TM) SURGICAL TAPE (K881509)Beiersdorf, Inc.1988-04-22
EXPANDOVER ELASTIC BANDAGE (K880207)Expandover C/O Hale and Dorr1988-04-21
POLYDERM PEC(TM), POROUS ELASTIC COVER (K880964)Laivan Corp.1988-03-17
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