Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
140401–140424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · LJC
Abbott Laboratories
Microbiology · 140d
Cleared Apr 29, 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · JTN
Difco Laboratories, Inc.
Microbiology · 104d
Cleared Apr 29, 1987
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG
K870201 · JTN
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Apr 29, 1987
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518 · FMF
Surgitek
General Hospital · 83d
Cleared Apr 29, 1987
CALCIUM TEST
K870629 · CIC
Sclavo, Inc.
Chemistry · 75d
Cleared Apr 29, 1987
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
K870946 · LJP
Serono Diagnostics, Inc.
Microbiology · 51d
Cleared Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
K870958 · CEF
Helena Laboratories
Chemistry · 50d
Cleared Apr 29, 1987
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
K871144 · DHN
Vitrotec Laboratories, Inc.
Immunology · 37d
Cleared Apr 29, 1987
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE
K871360 · MPB
Quinton, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 29, 1987
CONTROLCHEK(TM)
K871445 · JTO
Petra Biomedical Products, Inc.
Microbiology · 16d
Cleared Apr 29, 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456 · CFR
Biochemical Trade, Inc.
Chemistry · 16d
Cleared Apr 29, 1987
NEUTRAL RED
K871477 · KFE
Sigma Chemical Co.
Pathology · 15d
Cleared Apr 29, 1987
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
K871483 · KIZ
Isratech Marketing Corp.
Pathology · 14d
Cleared Apr 29, 1987
TITAN GEL IMMUNOFIX CONTROLS
K871498 · DFT
Helena Laboratories
Immunology · 13d
Cleared Apr 29, 1987
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532 · JTS
Remel Co.
Pathology · 9d
Cleared Apr 29, 1987
TOMTEC GRAM STAINER DECOLORIZER
K871533 · PPM
Remel Co.
Pathology · 9d
Cleared Apr 29, 1987
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Apr 29, 1987
METHYL GREEN SOLUTION
K871544 · HZA
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 29, 1987
NEW FUCHSIN SOLUTION
K871545 · IDF
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643 · LCP
Pacific Hemostasis
Hematology · 153d
Cleared Apr 28, 1987
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
K870067 · DQY
Vygon Corp.
Cardiovascular · 110d
Cleared Apr 28, 1987
CLEARVIEW CW-10
K870210 · GKR
Clearview Instruments, Inc.
Hematology · 98d
Cleared Apr 28, 1987
TOXOPLASMA IGM MICROASSAY
K870753 · LGD
Diamedix Corp.
Microbiology · 61d
Cleared Apr 28, 1987
THORASTAT ATR-XXXX
K870792 · DTP
Gish Biomedical, Inc.
Cardiovascular · 61d