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
153673–153696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1984
THREE PORT SENSOR MANIFOLD
K841637 · BZO
Dryden Corp.
Anesthesiology · 12d
Cleared May 01, 1984
LONG TERM CENTRAL VENOUS ACCESS CATH
K834299 · LJS
Burron Medical Products, Inc.
General Hospital · 145d
Cleared May 01, 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 141d
Cleared May 01, 1984
DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT
K834383 · LJS
Burron Medical Products, Inc.
General Hospital · 139d
Cleared May 01, 1984
GELSCAN SOFTWARE 2190
K834490 · JQP
Lkb Instruments, Inc.
Chemistry · 147d
Cleared May 01, 1984
BIOCERAM ZEST PLANT
K840244 · DZE
Zest Anchors, Inc.
Dental · 102d
Cleared May 01, 1984
CATEGORY 17-MICROBIOLOGY DEVICES
K840304 · HTD
Imm Enterprises , Ltd.
General & Plastic Surgery · 98d
Cleared May 01, 1984
BOSWORTH DENT-ALL
K840405 · EBI
Harry J. Bosworth Co.
Dental · 91d
Cleared May 01, 1984
RX ELAN
K840561 · EJS
Jeneric Ind.
Dental · 83d
Cleared May 01, 1984
RX C & B 20
K840563 · EJS
Jeneric Ind.
Dental · 83d
Cleared May 01, 1984
DIA THROMBIN DIA PLASTIN
K840802 · GJS
Diatech, Inc.
Hematology · 68d
Cleared May 01, 1984
BIOSURE
K840848 · JJW
Helena Laboratories
Hematology · 67d
Cleared May 01, 1984
URINARY MONITORING SYS 240
K840917 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 61d
Cleared May 01, 1984
URINE ANALYZER SYSTEM
K840996 · KQO
Kyoto Diagnostics, Inc.
Chemistry · 54d
Cleared May 01, 1984
SURGICAL RETRACTORS-VARIOUS
K841009 · GAD
Premier Dental Products Co.
General & Plastic Surgery · 53d
Cleared May 01, 1984
SURGICAL HOOKS, VARIOUS
K841010 · GDG
Premier Dental Products Co.
General & Plastic Surgery · 53d
Cleared May 01, 1984
WEIGHTED FEEDING TUBE W/PRE-INSERTED
K841014 · KNT
Ethox Corp.
Gastroenterology & Urology · 53d
Cleared May 01, 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · JHI
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared May 01, 1984
URIC ACID REAGENT SET ENZYMATIC
K841049 · KNK
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
TOTAL BILIRUBIN REAGENT SET
K841050 · CIG
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SERUM CALCIUM REAGENT SET
K841051 · CIC
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
CHOLESTEROL REAGENT SET
K841052 · CHD
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
CHOLESTEROL REAGENT SET ENZYMATIC
K841053 · CHH
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
DIRECT GLUCOSE REAGENT SET
K841054 · CGE
Medical Specialties, Inc.
Chemistry · 50d