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
174073–174096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613 · CFJ
Harleco Diagnostics
Chemistry · 78d
Cleared Jun 17, 1977
EXERCISER, LEG, LOWER EXTREMITY
K770658 · ION
Robert R. Moore
Physical Medicine · 71d
Cleared Jun 17, 1977
IN VITRO FERRITIN RIA TEST
K770702 · DBF
Clinical Assays, Inc.
Immunology · 60d
Cleared Jun 17, 1977
REAGENT, CHLORIDE, COULTER
K770752 · CHJ
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Jun 17, 1977
PHENYTOIN RIA KIT
K770779 · DLP
Amersham Corp.
Toxicology · 49d
Cleared Jun 17, 1977
RELAXATION COURSE MOLEL 1000
K770787 · HCC
Cybernetic Medical, Inc.
Neurology · 46d
Cleared Jun 17, 1977
SURGICAL COLDLIGHT, AX8
K770861 · FTD
Affiliated Hospital Products, Inc.
General & Plastic Surgery · 39d
Cleared Jun 17, 1977
TYGON PAC-MONITORING LINES & FLUID ADMIN
K770916 · FMG
Norton Performance Plastics Corp.
General Hospital · 29d
Cleared Jun 17, 1977
LIQUI SOL T4 RIA TEST KIT
K770918 · CDP
Damon Corp.
Chemistry · 29d
Cleared Jun 17, 1977
SUSPENSION SALINE, API 20E
K770926 · JTO
Analytical Products, Inc.
Microbiology · 38d
Cleared Jun 17, 1977
MIRACLELENS
K770955 · HQG
M.R.M. Optics, Inc.
Ophthalmic · 21d
Cleared Jun 17, 1977
LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS
K771003 · HNR
Edward Weck, Inc.
Ophthalmic · 15d
Cleared Jun 17, 1977
NEW PODIATRY PRODUCTS
K771005 · HTZ
Dentronix, Inc.
General & Plastic Surgery · 15d
Cleared Jun 17, 1977
MODIFIED PODIATRY PRODUCTS
K771006 · HTZ
Dentronix, Inc.
General & Plastic Surgery · 15d
Cleared Jun 17, 1977
SPINAL SURGERY FRAME
K771020 · JEB
Orthopedic Systems, Inc.
General & Plastic Surgery · 11d
Cleared Jun 15, 1977
TAPE, DERMICEL, CLOTH
K770362 · KGX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 112d
Cleared Jun 15, 1977
SPONGES, LAPAROTOMY
K770446 · EFQ
Walpak Co.
General & Plastic Surgery · 100d
Cleared Jun 15, 1977
TUBES, HYDROLYSIS, CALIBRATED
K770605
Organon, Inc.
Chemistry · 76d
Cleared Jun 14, 1977
ANALYZER, SODIUM/POTASSIUM NOVA L
K770601 · JGS
Nova Biomedical Corp.
Chemistry · 76d
Cleared Jun 14, 1977
QUANTIMUNE T-3 RIA
K770648 · CDP
Bio-Rad
Immunology · 70d
Cleared Jun 14, 1977
MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
K770687 · GRE
Microbiological Assoc.
Immunology · 62d
Cleared Jun 14, 1977
NEEDLE SET, A-V FISTULA
K770699 · FIE
Medical Disposables Intl., Inc.
Gastroenterology & Urology · 57d
Cleared Jun 14, 1977
FILTER UNIT, SINGLE USE
K770703 · FPB
Millipore Corp.
General Hospital · 57d
Cleared Jun 14, 1977
IV PUMP FILTERSET, UNIVERSAL
K770843 · FPB
Abbott Laboratories
General Hospital · 36d