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
161521–161544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1982
MALE EXTERNAL CATHETER
K820565 · KNX
Urocare Products, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 01, 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
K820573 · GKA
Helena Laboratories
Hematology · 30d
Cleared Apr 01, 1982
ROCHE B-HCG RIA
K820613 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
ROCHE B-HCG STANDARDS
K820614 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Apr 01, 1982
SYN-OPTICS #5200
K820624 · FET
Syn-Optics
Radiology · 24d
Cleared Apr 01, 1982
CORNING 480 FLAME PHOTOMETER
K820631 · JJO
Corning Medical & Scientific
Chemistry · 24d
Cleared Apr 01, 1982
RAICHEM TM CREATINE KINASE REAGENT
K820644 · CGS
Reagents Applications, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
EXHALED HYDROGEN MONITOR
K820652
Keymed, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
CM10 CENTRAL MONITORING SYSTEM
K820671 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 21d
Cleared Apr 01, 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · CIG
The Dow Chemical Co.
Chemistry · 21d
Cleared Apr 01, 1982
LIQUISOL PROGESTERONE RADIOIMMUNO
K820686 · JLS
Damon Corp.
Chemistry · 21d
Cleared Apr 01, 1982
DUPONT AUTOMATIC CLINICAL ANALYZER
K820687 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 21d
Cleared Apr 01, 1982
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · JIS
Syva Co.
Chemistry · 17d
Cleared Apr 01, 1982
EXTERNAL STANDARDS-SODIUMNPOTASSIUM
K820700 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
NOVA I FLUIDS PACK
K820701 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL
K820705 · JJS
United Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 01, 1982
NEONATAL INTRODUCER KIT
K820710 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Apr 01, 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · CIG
The Dow Chemical Co.
Chemistry · 17d
Cleared Apr 01, 1982
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · JKA
Sherwood Medical Co.
Hematology · 16d
Cleared Apr 01, 1982
COMPUTERIZED INTERPRETATION OF ARTERIAL
K820721 · JQP
Philip R. Corsello, M.D.
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · JHS
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEM. NH3
K820723 · JID
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1982
DIASCOPE 2
K820745 · DRT
Puritan Bennett Corp.
Cardiovascular · 13d
Cleared Apr 01, 1982
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
K820790 · FAM
American Optical Corp.
Gastroenterology & Urology · 9d