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
140473–140496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301 · CDT
American Monitor Corp.
Chemistry · 21d
Cleared Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319 · JHO
Helena Laboratories
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
K871320 · CDW
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
K871321 · CEO
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Apr 22, 1987
QM300 IGG ANTIBODY PACK
K871340 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · DEW
Helena Laboratories
Immunology · 16d
Cleared Apr 22, 1987
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared Apr 22, 1987
COLORIMETRIC URIC ACID REAGENT SET
K871417 · KNK
Biochemical Trade, Inc.
Chemistry · 15d
Cleared Apr 21, 1987
RAPID AS LATEX
K862530 · GTQ
Dilab, Inc.
Microbiology · 293d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS
K870410 · JTO
Diversified Diagnostic Industries
Microbiology · 77d
Cleared Apr 21, 1987
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422 · JTO
Gen-Probe, Inc.
Microbiology · 77d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION
K870561 · JTO
Diversified Diagnostic Industries
Microbiology · 70d
Cleared Apr 21, 1987
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
K871100 · BXK
Matheson Gas Products, Inc.
Anesthesiology · 33d
Cleared Apr 21, 1987
BIOCHEM 8090 CAPNOGRAPH
K871133 · CCK
Biochem International, Inc.
Anesthesiology · 32d
Cleared Apr 21, 1987
M-10 VENTILATION MONITOR
K871139 · CAP
Bio-Med Devices, Inc.
Anesthesiology · 29d
Cleared Apr 21, 1987
C.P.A.P. NASAL CANNULA
K871157 · BZD
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 28d
Cleared Apr 21, 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · BTR
Mallinckrodt Critical Care
Anesthesiology · 27d
Cleared Apr 21, 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · CZW
Dako Corp.
Immunology · 15d
Cleared Apr 21, 1987
KULTSURE
K871404 · JSM
Ncs Diagnostics, Inc.
Microbiology · 13d
Cleared Apr 20, 1987
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 187d
Cleared Apr 20, 1987
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
K864597 · LQF
Gen-Probe, Inc.
Microbiology · 147d
Cleared Apr 20, 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · JSM
Boots-Celltech Diagnostics, Inc.
Microbiology · 119d
Cleared Apr 20, 1987
ARTHROFLATOR
K865066 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 117d