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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
151801–151824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1984
VISION TESTER
K843042 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 64d
Cleared Oct 05, 1984
RING SUPPORTED TREPHINE FOR CORNEA TRANS
K843048 · HRH
Precision Instruments, Inc.
Ophthalmic · 63d
Cleared Oct 05, 1984
TRIA LENS SET
K843095 · HPC
Optek Medico Co., Ltd.
Ophthalmic · 59d
Cleared Oct 05, 1984
ROCHE REAGENT FOR ALT
K843111 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Oct 05, 1984
FRAME SPECTACLE
K843123 · HQZ
Vision Industries Corp.
Ophthalmic · 58d
Cleared Oct 05, 1984
VISITEC FLIERINGA-LEGRAND FIXATION RING
K843195 · HMH
Visitec Co.
Ophthalmic · 52d
Cleared Oct 05, 1984
VISITEC EYE SPECULUM
K843196 · HNC
Visitec Co.
Ophthalmic · 52d
Cleared Oct 05, 1984
VISITEC EYE SHIELD
K843197 · HMP
Visitec Co.
General & Plastic Surgery · 52d
Cleared Oct 05, 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283 · JJE
Boehringer Mannheim Corp.
Chemistry · 46d
Cleared Oct 05, 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · DHN
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 39d
Cleared Oct 05, 1984
EMIT 700 CANNABINOID CONTROL SET
K843419 · LAS
Syva Co.
Toxicology · 35d
Cleared Oct 05, 1984
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
K843434 · JQC
Iso-Data, Inc.
Chemistry · 31d
Cleared Oct 05, 1984
CILCO DIAMOND KNIFE
K843447 · HNN
Cilco, Inc.
Ophthalmic · 30d
Cleared Oct 05, 1984
CONCEPT FIBER OPTIC CANALICULUS INTUBA
K843491 · HNL
Concept, Inc.
Ophthalmic · 29d
Cleared Oct 05, 1984
EMIT D.A.U. COCAINE ASSAY
K843556 · DIO
Syva Co.
Toxicology · 25d
Cleared Oct 05, 1984
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565 · JJW
Icl Scientific
Chemistry · 25d
Cleared Oct 05, 1984
FIAX HAPTOGLOBIN TEST KIT
K843570 · DAB
Intl. Diagnostic Technology
Immunology · 24d
Cleared Oct 05, 1984
VICO MICRO SURGICAL INSTRUMENTS
K843592 · HWQ
Visitec Co.
Orthopedic · 23d
Cleared Oct 05, 1984
BREATHABLE MINI-SHIELD-PRIVATE LABEL
K843602 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 23d
Cleared Oct 05, 1984
EMIT 700 METHAQUALONE ASSAY
K843605 · KXS
Syva Co.
Toxicology · 22d
Cleared Oct 05, 1984
PERSPECTIVE CHEMICAL ANALYZER
K843610 · JJE
American Monitor Corp.
Chemistry · 22d
Cleared Oct 05, 1984
CORNING IMMUNOFIXATION SYS
K843614 · CZP
Corning Medical & Scientific
Chemistry · 21d
Cleared Oct 05, 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679 · DIF
Quantimetrix Corp.
Chemistry · 17d
Cleared Oct 05, 1984
SCLAVO CHLORIDE TEST
K843740 · CHJ
Sclavo, Inc.
Chemistry · 10d