Atlas FDA

FQM

42 FDA 510(k) clearances · Product code

27 daysmedian time to decision
106 days90th percentile
42clearances measured

FDA profile

Official device name
Bandage, Elastic
Device class
Class I (low risk)
Regulation
21 CFR 880.5075
Medical specialty
General Hospital
Flags
GMP exempt
Adverse events (MAUDE)
2015: 8 · 2016: 10 · 2018: 13 · 2020: 64 · 2021: 73 · 2022: 23
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
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (K040936)Leda Co., Ltd.2004-05-03
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE (K040054)Theodore Barash2004-04-27
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE (K013244)Med Gen, Inc.2001-12-07
SKIN SAVER SYSTEMS (K952738)Skin Saver Systems, Inc.1995-09-29
ASPEN ESMARK BANDAGE (K872868)Aspen Laboratories, Inc.1987-07-31
TUBE-BANDAGE FOR HUMAN DIGITS 200 (K840107)Zens Health Care Products1984-04-25
MEDICALEX (K831728)Medicalex1984-01-09
ORTHO WRAP (K830622)Fast Wrap Co., Inc.1983-06-20
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE (K831551)Fred Sammons, Inc.1983-06-07
BIAS STOCKINETTE (K820141)Stan-Pak Ent.1982-02-05
TUBULAR STOCKINETTE (K820142)Stan-Pak Ent.1982-02-05
ELASTIC BANDAGE (K820094)Stan-Pak Ent.1982-01-29
STRUVA & MEDI (K811173)Weco1981-06-18
SOF-BAND HIGH STRETCH BANDAGES (K810137)Johnson & Johnson Professionals, Inc.1981-02-17
ROLL STRETCH GAUZE (K802991)Abco Dealers, Inc.1980-12-30
ELASTIC GAUZE (K802992)Abco Dealers, Inc.1980-12-30
ELASTIC BANDAGE (K802785)Secol Co.1980-12-11
ELASTIC OPEN WEAVE BANDAGE (K802784)Secol Co.1980-12-10
TUBULAR BANDAGE (K802789)Secol Co.1980-12-10
FINGER PAINGUARD CAT.#193-194 (K802015)Pollak (Intl.), Ltd.1980-09-09
ELASTIC BANDAGE CAT.#182-186 (WIDTH) (K801990)Pollak (Intl.), Ltd.1980-09-09
STOCKINETTE, STERILE TWO PLY W/PULL TABS (K801532)The Owenby Co.1980-07-28
WINTER HEAD DRESSING (K801458)Steridyne Corp.1980-07-28
MEDSPEC RUBBER ELASTIC BANDAGES (K800280)Medspec Corp.1980-03-12
ANAGO DISP., ALL PURPOSE PATIENT REST. (K800197)Anago, Inc.1980-02-26
TOMMY TOES (K792331)Tommy Toes1979-12-20
POROUS ELASTIC RUBBER BANDAGE (K792065)Norman R. Sanborn Co.1979-11-20
SECUTEX SURGICAL BINDER (K791256)Conphar, Inc.1979-08-03
BINDAFIX (K791211)Conphar, Inc.1979-08-03
STOCKINETTE, TUBULAR UNBLEACHED (K790210)The Owenby Co.1979-02-27
TAPE, ELASTOPLAST ELASTIC TEAR (K781931)Beiersdorf, Inc.1978-12-07
BANDAGE (K780606)Abco Dealers, Inc.1978-04-19
TUBULAR DRESSING RETAINER (K780570)Alba-Waldensian, Inc.1978-04-19
BANDAGE, ELASTIC (K780231)Biomet, Inc.1978-02-21
ELASTOMULL GAUZE BANDAGE (K771758)Beiersdorf, Inc.1977-10-13
CONFORM ELASTIC NETTING (K771563)Kendall Research Center1977-09-12
BANDAGE, UNIPRESS, CLARION (K770958)Sherwood Medical Industries1977-06-14
BANDAGE, E-COTTON ELASTIC (K760139)Conco Medical Co.1976-07-19
BANDAGE, RAPIDO-LASTIC COTTON/NYLON (K760142)Conco Medical Co.1976-07-19
BANDAGE, WRINKY-LASTIC ELASTIC GAUZE (K760140)Conco Medical Co.1976-07-19
BANDAGE, CEB COTTON ELASTIC (K760138)Conco Medical Co.1976-07-19
BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC (K760141)Conco Medical Co.1976-07-19

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Every clearance here is in the API, with alerts when new ones post.