FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136249–136272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1988
SUN SHELL (SUN TANNING BED)
K881409 · LEJ
Indoor Sun Systems, Inc.
General & Plastic Surgery · 15d
Cleared Apr 19, 1988
SPIRIX(TM)
K881427 · GEI
Medical/Surgical Specialties, Ltd.
General & Plastic Surgery · 14d
Cleared Apr 19, 1988
MTI WOLFF SYSTEM, TANNING BED
K881492 · LEJ
Health Systems Intl., Inc.
General & Plastic Surgery · 11d
Cleared Apr 18, 1988
SIM 4000C
K874548 · IYO
Ote-Biomedica Elettronica S.P.A
Radiology · 167d
Cleared Apr 18, 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · IYO
Elscint, Inc.
Radiology · 152d
Cleared Apr 18, 1988
ALBUMIN CAT. # 201-03
K875207 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
CHLORIDE CAT. # 152-17
K875208 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
JETPOLISHER AIRPOLISHING POWDER
K875339 · EJR
Young Dental Manufacturing Co. 1, LLC
Dental · 110d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087 · CDP
Abbott Laboratories
Chemistry · 97d
Cleared Apr 18, 1988
KENSEY CATHETER
K880194 · LIT
Theratek, Inc.
Cardiovascular · 90d
Cleared Apr 18, 1988
URIC ACID REAGENT SET
K880277 · KNK
Tech-Neal Scientific, Inc.
Chemistry · 88d
Cleared Apr 18, 1988
ILLUMINA 40 CO2 LASER SYSTEM
K880427 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
ILLUMINA 25 CO2 LASER SYSTEM
K880428 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
ILLUMINA 55 CO2 LASER SYSTEM
K880429 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
INTERCEPT T.E.N.S. DEVICE
K880492 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 74d
Cleared Apr 18, 1988
DEXPAD, BLOOD GLUCOSE STRIP
K880585 · CGA
Mach Diag. C/O Wichita State University
Chemistry · 68d
Cleared Apr 18, 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · KHQ
Syva Co.
Chemistry · 62d
Cleared Apr 18, 1988
CAPCADDY
K880621 · EJI
Capcad, Inc.
Dental · 62d
Cleared Apr 18, 1988
LABCO LIMITED EXETAINER(R)
K880622 · JKA
Labco, Ltd.
Chemistry · 62d
Cleared Apr 18, 1988
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
K880758 · CEP
Boots-Celltech Diagnostics, Inc.
Chemistry · 53d
Cleared Apr 18, 1988
G-CERA PORCELAIN BOND
K880765 · EBF
G-C Intl. Corp.
Dental · 52d
Cleared Apr 18, 1988
PORCELAIN PRIMER
K880790 · DYH
Reliance Orthodontic Products, Inc.
Dental · 52d
Cleared Apr 18, 1988
PLASTIC PRIMER
K880792 · DYH
Reliance Orthodontic Products, Inc.
Dental · 52d