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
172993–173016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1977
FIAX C4 ASSAY
K772114 · DAK
Idt, A Division of Whittaker M.A....
Immunology · 23d
Cleared Nov 30, 1977
URINARY VMA - SCREEN TEST KIT
K772151 · CDF
Eppendorf-Brinkmann, Inc.
Chemistry · 15d
Cleared Nov 30, 1977
CERVICAL TRACTION DIV., PNEUMATIC
K772154 · ITH
Jobst
Physical Medicine · 16d
Cleared Nov 30, 1977
MOLDEYE
K772168 · HQN
Robert B. Scott Ocularists of...
Ophthalmic · 22d
Cleared Nov 30, 1977
LAPAROSCOPE W/REMOVABLE OPTICS
K772185 · HET
Kli
Obstetrics & Gynecology · 5d
Cleared Nov 29, 1977
CATHETER, UMBILICAR ARTERY
K771022 · FOS
Axiom Medical, Inc.
General Hospital · 176d
Cleared Nov 29, 1977
ELECTROSURGICAL GENERATOR
K771639 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 95d
Cleared Nov 29, 1977
IRRIGATING NEEDLE, ILLUMINATED
K771785
Concept, Inc.
General & Plastic Surgery · 67d
Cleared Nov 29, 1977
CATHETER, VEIN, FEMORAL, SF 10
K772146 · FJT
Sorensen Research
Hematology · 15d
Cleared Nov 29, 1977
CATHETER, FEMORAL VEIN, SF 6
K772148 · FJT
Sorensen Research
Hematology · 15d
Cleared Nov 28, 1977
LIGACLIP MULTIPLE CLIP APPLIER
K771412 · GDO
Ethicon, Inc.
General & Plastic Surgery · 119d
Cleared Nov 28, 1977
LIGACLIP MULTIPLE LIGATING CLIPS
K771413 · FZP
Ethicon, Inc.
General & Plastic Surgery · 119d
Cleared Nov 28, 1977
BETA-CAP
K771420 · FJS
Quinton, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 28, 1977
CATHETER FINGER GRIP
K771483 · FJS
Quinton, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 28, 1977
PERITONEAL DIALYSIS CATHETER
K771555 · FJS
Fluoro-Mold Co.
Gastroenterology & Urology · 108d
Cleared Nov 28, 1977
ARMOR-KOT SURGICAL INSTRUMENTS
K771680 · FSM
Storz Instrument Co.
General & Plastic Surgery · 83d
Cleared Nov 28, 1977
HEMATOLOGY REFERENCE CONTROL
K771753 · JPK
Coulter Electronics, Inc.
Hematology · 73d
Cleared Nov 28, 1977
SPECTROPHOTOMETER ANALYSIS SYS.
K771807 · JJQ
Varian Assoc., Inc.
Chemistry · 63d
Cleared Nov 28, 1977
CATHETER, CEBTRAL VENOUS, 2N1501
K771861 · JCY
Travenol Laboratories, S.A.
General & Plastic Surgery · 56d
Cleared Nov 28, 1977
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110
K771865 · FSY
Castle Co.
General & Plastic Surgery · 56d
Cleared Nov 28, 1977
HEARTBEATER
K771924 · DXG
Dunn Instruments, Inc.
Cardiovascular · 46d
Cleared Nov 28, 1977
ACUTE CARDIAC CARE SYSTEM
K772006 · DRT
Physio-Control Corp.
Cardiovascular · 38d
Cleared Nov 28, 1977
CARDIAC PACEMAKER S6001
K772009 · DXY
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
CARDIAC PACEMAKER C2001
K772010 · DXY
Vitatron Medical BV
Cardiovascular · 34d