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
174001–174024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1977
GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT
K761089 · CHH
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Jan 25, 1977
UNIVAL CONTROL CELLS
K761284 · KSF
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 36d
Cleared Jan 25, 1977
GLUCOSE KIT
K761320 · CFR
Environmental Chemical Specialties
Chemistry · 29d
Cleared Jan 25, 1977
PIPETTING DEVICES
K770013 · JQW
Kensington Scientific
Immunology · 22d
Cleared Jan 25, 1977
CYANOBOND
K770067 · EMA
Parker Laboratories, Inc.
Dental · 13d
Cleared Jan 25, 1977
PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.
K770073 · DXK
Rohe Scientific Corp.
Cardiovascular · 12d
Cleared Jan 25, 1977
KESSELL TOTAL SHOULDER
K770079
Orthopedic Equipment Co., Inc.
Orthopedic · 11d
Cleared Jan 25, 1977
BAKER MOBILE TRACTION
K770080 · HST
Orthopedic Equipment Co., Inc.
Neurology · 11d
Cleared Jan 25, 1977
SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK
K770101 · HNR
Edward Weck, Inc.
Ophthalmic · 8d
Cleared Jan 25, 1977
HOOK, IRIS, SHEPARD U-SHAPED
K770103 · HNQ
Edward Weck, Inc.
Ophthalmic · 8d
Cleared Jan 25, 1977
SHEPARD II, LENS FORCEP W/ LOCK
K770105 · HNR
Edward Weck, Inc.
Ophthalmic · 8d
Cleared Jan 24, 1977
X-RAY POSITIONING DEVICE
K770060 · KPR
Robert R. Moore
Radiology · 13d
Cleared Jan 24, 1977
EMERGENCY FAST-FIX DENTURE REPAIR KIT
K770091 · EBO
Mr. Clarence Hurst
Dental · 7d
Cleared Jan 24, 1977
DENTAL BURS
K770093 · EJL
The S. S. White Co.
Dental · 7d
Cleared Jan 24, 1977
HERSHMAN LENS FORCEPS WITH IRRIGATOR
K770097 · HNR
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
HOOK, IRIS, HERSHMAN
K770098 · HNQ
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK
K770099 · HNR
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
BINKHORST LENS FORCEP W/ IRRIGATOR
K770100 · HNR
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
HERSHMAN LENS FORCEPS W/OUT IRRIGATOR
K770102 · HNR
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
BINKHORST LENS FORCEPS W/OUT IRRIGATOR
K770104 · HNR
Edward Weck, Inc.
Ophthalmic · 7d
Cleared Jan 24, 1977
ENAMELITE ENAMEL COATING
K770109 · EBF
Lee Pharmaceuticals
Dental · 7d
Cleared Jan 21, 1977
STIMULATOR, PNEUMATIC
K760214
O. F. Anderson
Physical Medicine · 193d
Cleared Jan 21, 1977
AUTOMATIC ELECTRONIC SPHYGMOMANOMETER
K760738 · DXN
Medical Monitors, Inc.
Cardiovascular · 115d
Cleared Jan 21, 1977
MARKET CASTLE UNISPHERE
K761015 · FRC
Castle Co.
General Hospital · 73d