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
161929–161952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1982
RAPID ZYME
K813612 · JTO
Dms Laboratories
Microbiology · 55d
Cleared Feb 22, 1982
RAPID CH
K813613 · JTO
Dms Laboratories
Microbiology · 55d
Cleared Feb 22, 1982
VERSATOME I
K820008 · HQE
Alphamedix, Inc.
Ophthalmic · 49d
Cleared Feb 22, 1982
URETHAL CUTTER CLAMP
K820015 · KOA
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 48d
Cleared Feb 22, 1982
CERILLIUM
K820049 · EJH
Jelrus Technical Products Corp.
Dental · 45d
Cleared Feb 22, 1982
REVERSIBLE HYDROCOLLOID IMPRESSION MAT
K820061 · ELW
Belport Co., Inc.
Dental · 42d
Cleared Feb 22, 1982
CLOTTING TIME REAGENT
K820084 · GJB
American Dade
Hematology · 41d
Cleared Feb 22, 1982
INTELECT MODEL 700
K827033
Chattanooga Group, Inc.
Radiology · 48d
Cleared Feb 22, 1982
INTELECT MODEL 200
K827034
Chattanooga Group, Inc.
Radiology · 48d
Cleared Feb 19, 1982
MODEL 500 VERI/500
K813108 · IPF
Verite
Physical Medicine · 108d
Cleared Feb 19, 1982
ELECTROC-GYM
K813181 · IPF
Electrola
Physical Medicine · 99d
Cleared Feb 19, 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · FKX
Erika, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 18, 1982
TNS MK I STIMULATOR
K812612 · GZJ
Edu Kit , Ltd.
Neurology · 156d
Cleared Feb 18, 1982
MODEL 2650 HIGH CAPACITY DUAL SYRINGE
K813644 · FRN
Harvard Apparatus, Inc.
General Hospital · 49d
Cleared Feb 18, 1982
WELLCOGEN GROUP B
K820069 · GTZ
Burroughs Wellcome Co.
Microbiology · 37d
Cleared Feb 18, 1982
SIEMENS SIRESKOP 4
K820111 · KXJ
Siemens Corp.
Radiology · 34d
Cleared Feb 18, 1982
AUTOMATIC TRAY (ACT I & ACT II
K820117 · KPX
Burbury & Cutter Ind., Inc.
Radiology · 31d
Cleared Feb 18, 1982
PODIOSCOPE BY ARROW
K820119 · KPW
Arrow X-Ray Corp.
Radiology · 31d
Cleared Feb 18, 1982
THEIR ELECTRO SURGICAL COUTERY PENCIL
K820156 · GEI
Shannon Group
General & Plastic Surgery · 30d
Cleared Feb 18, 1982
LAMINATED KARAYA GUM WASHERS
K820167 · EXB
Atlantic Surgical
Gastroenterology & Urology · 28d
Cleared Feb 18, 1982
VENTILATOR MODELS
K820220 · CBK
Pneupac , Ltd.
Anesthesiology · 22d
Cleared Feb 18, 1982
PREFILLED SPECIMEN CONTAINER
K820246 · KDT
Sage Products, Inc.
Pathology · 20d
Cleared Feb 18, 1982
EXTERNAL VENTRICULAR DRAINAGE SYS.
K820247 · JXG
American Heyer Schulte
Neurology · 20d
Cleared Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d