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
144145–144168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · DTB
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 13, 1986
GALENICA'S DISPOSABLE ANOSCOPES
K861017 · FER
Galenica Enterprises, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 13, 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 74d
Cleared Jun 13, 1986
MUREX SUDS RUBELLA
K861282 · LFX
Murex Corp.
Microbiology · 67d
Cleared Jun 13, 1986
RESPISOMNOGRAPH
K861326 · BZQ
Dickstein, Shapiro & Morin
Anesthesiology · 66d
Cleared Jun 13, 1986
SYVA SOLID PHASE COLUMNS SYSTEM II
K861392 · KZR
Syva Co.
Chemistry · 60d
Cleared Jun 13, 1986
MUREX SUDS TOXO
K861458 · LGD
Murex Corp.
Microbiology · 56d
Cleared Jun 13, 1986
DOCUMENT ENZYME LINEARITY TEST SETS
K861506 · JJT
Casco Standards
Chemistry · 51d
Cleared Jun 13, 1986
EMIT CAFFEINE CONTROL
K861511 · LAS
Syva / A Syntex Co.
Toxicology · 51d
Cleared Jun 13, 1986
ALBUMIN PROCEDURE
K861654 · CIX
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
CHOLESTEROL PROCEDURE
K861659 · CHH
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
URIC ACID PROCEDURE
K861660 · KNK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TOTAL PROTEIN PROCEDURE
K861663 · CEK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TIPSEP-TBG ASSAY
K861735 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 13, 1986
FLUOROSCOPE BAND BAG
K861785 · JAA
Medi-Plast Intl., Inc.
Radiology · 36d
Cleared Jun 13, 1986
BIOSIL F
K861820 · EJH
Degussa Dental, Inc.
Dental · 32d
Cleared Jun 13, 1986
TITANIUM HEMOSTATIC CLIPS
K861922 · FZP
Pilling Co.
General & Plastic Surgery · 25d
Cleared Jun 13, 1986
MODEL 100 NERVE STIMULATOR
K861935 · BXN
National Medical Sales, Inc.
Anesthesiology · 24d
Cleared Jun 13, 1986
LEE-BEAD PROLACTIN (EIA)
K861945 · CFT
Leeco Diagnostics, Inc.
Chemistry · 24d
Cleared Jun 13, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET
K861967 · JGS
American Research Products Co.
Chemistry · 24d
Cleared Jun 13, 1986
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET
K861968 · CEO
American Research Products Co.
Chemistry · 24d
Cleared Jun 13, 1986
LDP REAGENT CARTRIDGE (NO. 88216)
K862027 · CFJ
Hi Chem, Inc.
Chemistry · 16d
Cleared Jun 13, 1986
MICROSCOPE SLIDES
K862112 · LIB
Abco Dealers, Inc.
Microbiology · 10d
Cleared Jun 13, 1986
HISTOLOGY PARAFFIN
K862141 · KEO
Erie Scientific Co.
Pathology · 9d