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
156097–156120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1983
AUTOMATIC ENDOSCOPE
K832458 · NVE
American Endoscopy, Inc.
General Hospital · 86d
Cleared Oct 20, 1983
PORTABLE LIFECARE VENTILATOR PLV-100
K832467 · CBK
Lifecare Services, Inc.
Anesthesiology · 79d
Cleared Oct 20, 1983
ASPIRATING TUBING
K832519 · GAZ
Wells Johnson Co.
General Hospital · 73d
Cleared Oct 20, 1983
SUCTION TIPS
K832520 · GEA
Wells Johnson Co.
General & Plastic Surgery · 73d
Cleared Oct 20, 1983
PLASTIC SUCTION TIPS
K832521 · GEA
Wells Johnson Co.
General & Plastic Surgery · 73d
Cleared Oct 20, 1983
MGI STRENGTH/FITNESS SYS-MODEL #PU-101
K832528 · JOM
Mgi Strength/Fitness Systems, Inc.
Cardiovascular · 93d
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESS. MEASUREMENT CATH
K832579 · DXO
Camino Laboratories, Inc.
Cardiovascular · 79d
Cleared Oct 20, 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH
K832604 · DXO
Camino Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 20, 1983
ULTRA LIGHT RAAF CATHETER
K832784 · DQY
Quinton, Inc.
Cardiovascular · 65d
Cleared Oct 20, 1983
FIXATION STAPLE DRIVER/EXTRACTOR
K832884 · JDR
Warsaw Orthopedic, Inc.
Orthopedic · 55d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · DTB
Pacesetter Systems
Cardiovascular · 49d
Cleared Oct 20, 1983
PURGES LINES, PL-45 & PL-33
K833048 · DTM
American Bentley
Cardiovascular · 44d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · DTB
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
OXFORD MARK 2 EXTERNAL FIXATOR
K833114 · JEC
Johnson & Johnson Professionals, Inc.
Orthopedic · 37d
Cleared Oct 20, 1983
TRI-COUNT 7
K833130 · JPK
Hematology Marketing Assoc.
Hematology · 37d
Cleared Oct 19, 1983
VIDEO-DILUTION TECH. MARK I INSTRUMENT
K831057 · DXG
Angio Tec Corp.
Cardiovascular · 201d
Cleared Oct 19, 1983
TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO
K831245 · DXN
Ritter Co.
Cardiovascular · 184d
Cleared Oct 19, 1983
TEMP. REPAIR KIT-DUAL LUMEN CATHETER
K831587 · LJS
Norton Performance Plastics Corp.
General Hospital · 155d
Cleared Oct 19, 1983
KARICKHOFF FLYING CORPUSCLE VIEWER
K831829 · HIX
Surgidev Corp.
Ophthalmic · 134d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY COMPOSITE
K831865 · DSY
Shiley, Inc.
Cardiovascular · 131d
Cleared Oct 19, 1983
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
K831880 · DSY
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 19, 1983
BLOOD OXYGENATOR 50 70/S
K831895 · DTZ
Shiley, Inc.
Cardiovascular · 127d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943 · DRT
Hewlett-Packard Co.
Cardiovascular · 125d