FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
173233–173256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 14, 1977
DIALYZER, ULTRADIFFUSER, DISPOSABLE
K770858 · FJG
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 14, 1977
FLU VEN 0160
K770863 · FPA
Venospital, Inc.
General Hospital · 34d
Cleared Jun 14, 1977
MONITOR, PACEMAKER
K770865 · DTC
Adcor Electronics, Inc.
Cardiovascular · 34d
Cleared Jun 14, 1977
DIALYZER, FIBER, HOLLOW
K770867 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Jun 14, 1977
TSH RADIOIMMUNOASSAY
K770892 · JLW
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 14, 1977
CLASP RIA KIT, HTSH
K770915 · JLW
E. R. Squibb & Sons, Inc.
Immunology · 26d