Atlas FDA

GBI

17 FDA 510(k) clearances · Product code

37 daysmedian time to decision
157 days90th percentile
17clearances measured

FDA profile

Official device name
Material, External Aesthetic Restoration, Used With Adhesive
Device class
Class I (low risk)
Regulation
21 CFR 878.3800
Medical specialty
General, Plastic Surgery
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RecordFirmDate
FACTOR II PROSTHETIC SILICONE ELASTOMER (K880329)Factor, Ii, Inc.1988-06-01
AHH NATURAL BREAST FORM (K874279)Pacific Prosthetics, Inc.1987-10-29
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (K872714)Roseburg SA1987-07-21
AMOENA BREAST FORMS (K864785)Coloplast Corp.1987-01-08
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (K864786)Coloplast Corp.1987-01-08
AMOENA BREAST FORMS (K853822)Coloplast Corp.1985-09-30
PROSTHESIS OR SURGICAL PADS (K851668)Virginia Hall, Inc.1985-06-04
SILIMED BREAST FORM (K842765)Sil-Med Corp.1984-08-17
CONFORMA (K841559)Beiersdorf, Inc.1984-07-17
TRILICON BREASE PROSTHESIS DIFFERENT (K841171)Baurs Krey Assoc., Inc.1984-04-25
PDM SILOXANE PROSTHETIC ORBIT (K832151)Delaware Prosthetics, Inc.1983-12-19
PDM SILOXANE PROSTHETIC EAR (K832152)Delaware Prosthetics, Inc.1983-12-09
PDM SILOXANE PROSTHETIC NOSE (K832153)Delaware Prosthetics, Inc.1983-12-09
TRULIFE SILICONE BREAST FORM (K831831)Medeering, Ltd.1983-06-30
EXTERNAL BREAST PROSTHESIS (K813416)Surgical Appliance Industries, Inc.1982-01-18
IPOS BREAST PROSTHESIS (K792372)Ipos KG1979-12-19
IMPLANTING OF POLYACRYLIC FIBERS (K770359)Allan V. Marse1977-04-08

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