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
144793–144816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1986
THABEST-IGE
K855053 · DHB
Visual Diagnostics, Inc.
Immunology · 126d
Cleared Apr 22, 1986
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · DHR
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Apr 22, 1986
FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
K860027 · DHB
Alerchek, Inc.
Immunology · 109d
Cleared Apr 22, 1986
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
K860100 · LHO
Victoreen, Inc.
Radiology · 102d
Cleared Apr 22, 1986
IV7200 AND IV7400 INFUSION PUMP
K860694 · FRN
Valleylab, Inc.
General Hospital · 56d
Cleared Apr 22, 1986
ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
K861015 · FOZ
Acme United Corp.
General Hospital · 35d
Cleared Apr 22, 1986
LIC MOBILE TRANSPORT STRETCHERS
K861410 · FPO
Lada Intl., Inc.
General Hospital · 7d
Cleared Apr 21, 1986
SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
K853089 · ELW
Psp Dental Co., Ltd.
Dental · 272d
Cleared Apr 21, 1986
CORDIA CMV-M
K853889 · LKQ
Cordis Corp.
Microbiology · 214d
Cleared Apr 21, 1986
MICRO-ELISA HLH TEST KIT MONOCLONAL
K860333 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
VISI-CHECK HLH TEST MONOCLONAL
K860334 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
MUREX (TM), SUDS (TM), HCG ASSAY
K860451 · LCX
Murex Corp.
Chemistry · 75d
Cleared Apr 21, 1986
BLOOD UREA NITROGEN (BUN) TESTCARD
K860543 · CDS
Ilex Corp.
Chemistry · 67d
Cleared Apr 21, 1986
LATEX R. TYPHI
K860557 · GPM
Health Research, Inc.
Microbiology · 66d
Cleared Apr 21, 1986
IONIZED CALCIUM AND BLOOD PH TESTCARDS
K860639 · JFP
Ilex Corp.
Chemistry · 60d
Cleared Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · LFR
Trace Scientific , Ltd.
Chemistry · 54d
Cleared Apr 21, 1986
AM-100 I/A AMPAC
K860770 · HQC
Dravon Medical, Inc.
Ophthalmic · 49d
Cleared Apr 21, 1986
WRAPPERS, SUNGLASSES
K860794 · HQG
Mhci Corp.
Ophthalmic · 48d
Cleared Apr 21, 1986
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
K860891 · HQE
Intra-Optics Labs. C/O Newman Assoc.
Ophthalmic · 42d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002 · CKA
Abbott Laboratories
Chemistry · 34d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
K861301 · JTZ
Troy Biologicals, Inc.
Microbiology · 14d
Cleared Apr 18, 1986
AMBULASE
K852436 · GEX
Xanar, Inc.
General & Plastic Surgery · 312d