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
149593–149616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1985
EMIT 700 METHADONE ASSAY
K850953 · DJR
Syva Co.
Toxicology · 25d
Cleared Apr 01, 1985
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · CEO
Data Medical Associates, Inc.
Chemistry · 21d
Cleared Apr 01, 1985
URI-KIT
K850998 · JSG
Culture Kits, Inc.
Microbiology · 21d
Cleared Apr 01, 1985
EYEDENTITY EYEWEAR
K851039 · HQZ
Vitech Research C/O Johnsen, Manfredi...
Ophthalmic · 18d
Cleared Apr 01, 1985
DERAPAGE EYEWEAR BY VITALONI
K851062 · HQY
Vitaloni S.P.A.
Ophthalmic · 17d
Cleared Apr 01, 1985
SPOTTEST INDIA INK
K851184 · JTO
Difco Laboratories, Inc.
Microbiology · 6d
Cleared Mar 29, 1985
URI-VAL
K843680 · JMZ
Cenogenics Corp.
Chemistry · 192d
Cleared Mar 29, 1985
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · CIB
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Mar 29, 1985
LASER-GLOBIN POWDER
K850094 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-DIL
K850095 · GIF
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-GLOBIN
K850096 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-LYSE
K850097 · GGK
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
BETASONIC III
K850116 · IYO
Teknar, Inc.
Radiology · 74d
Cleared Mar 29, 1985
ISOENZYME TEST LD-1
K850210 · CFE
Sclavo, Inc.
Chemistry · 73d
Cleared Mar 29, 1985
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
K850487 · DSF
Novametrix Medical Systems, Inc.
Cardiovascular · 50d
Cleared Mar 29, 1985
TRYPSIN-EDTA SOLUTION
K850679 · KIT
Hazleton Research Products, Inc.
Pathology · 36d
Cleared Mar 29, 1985
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ
K850832 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 42d
Cleared Mar 29, 1985
ICS THEOPHYLLINE REAGENTS
K850856 · KLS
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Mar 29, 1985
I/A HANDPIECE
K850857 · HQE
Medical Instrument Development...
Ophthalmic · 28d
Cleared Mar 29, 1985
I/A BAC STOP KIT
K850899 · HQC
Staar Surgical Co.
Ophthalmic · 25d
Cleared Mar 29, 1985
PHACO-BAC STOP KIT
K850900 · HQC
Staar Surgical Co.
Ophthalmic · 25d
Cleared Mar 29, 1985
NSI LYSING-D REAGENT -4000 ML
K850944 · GGK
Nobel Scientific Industries, Inc.
Hematology · 22d
Cleared Mar 29, 1985
INHIBITORY MOLD AGAR PLATE
K850969 · JSJ
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Mar 29, 1985
BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA
K850970 · JSJ
Granite Diagnostics, Inc.
Microbiology · 21d