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
169921–169944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1979
KETOSTEROID TEST, HYCEL-17
K782116 · CCY
Hycel, Inc.
Chemistry · 30d
Cleared Jan 26, 1979
FUL-VUE
K782118 · HKN
American Optical Corp.
Ophthalmic · 30d
Cleared Jan 26, 1979
GLUCOSE REAGENT SYSTEM
K782136 · CFR
American Monitor Corp.
Chemistry · 30d
Cleared Jan 26, 1979
LEVIGATOR, KEELER PHOKO
K782141 · HQC
Keeler Optical Products , Ltd.
Ophthalmic · 30d
Cleared Jan 26, 1979
ILLIMINATOR, MODEL 265 NASAL
K782142 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 30d
Cleared Jan 26, 1979
TOTAL IRON IN SERUM
K782160 · JIY
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Jan 26, 1979
HYCEL LDH-INT TEST
K782176 · CFH
Hycel, Inc.
Chemistry · 29d
Cleared Jan 26, 1979
RHEUMOGEN TEST SYSTEM
K790012 · DHR
Calbiochem-Behring Corp.
Immunology · 24d
Cleared Jan 26, 1979
SONO TRAK T.M.
K790037 · IYO
Narco Air-Shields
Radiology · 18d
Cleared Jan 26, 1979
DISK, BETA-LACTAM
K790038 · JTO
Remel Co.
Microbiology · 18d
Cleared Jan 26, 1979
G-HB QUIK COLUMN CONTROL
K790046 · LCP
Helena Laboratories
Hematology · 21d
Cleared Jan 26, 1979
KELLEY-PLUS WITH MEASURETTE
K790053 · KKX
John N. Haswell, M.D.
General Hospital · 17d
Cleared Jan 26, 1979
BUCKYMAT
K790069 · KPR
Siemens Corp.
Radiology · 14d
Cleared Jan 26, 1979
SIREGRAPH B-150
K790070 · KPR
Siemens Corp.
Radiology · 14d
Cleared Jan 26, 1979
APRON, LEADED VINYL
K790080 · KPY
Pinnacle Distributors, Inc.
Radiology · 14d
Cleared Jan 26, 1979
CAMERA, CLEON 720 LARGE FIELD GAMMA
K790081 · IYX
Union Carbide Corp.
Radiology · 14d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (SUPER)
K790093 · ESD
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (COMPRESSION)
K790094 · ESD
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
MODULE PERSONAL EAR (DELUXE)
K790095 · ESD
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
K790126 · JXG
Holter-Hausner Intl.
Neurology · 2d
Cleared Jan 25, 1979
SCANNER-SV
K782158 · IYO
Hrl, Inc.
Radiology · 34d
Cleared Jan 25, 1979
ARTERIAL EXTENSION SET
K790082 · DQO
Namic
Cardiovascular · 13d
Cleared Jan 25, 1979
CATHETER, ARTERIAL LINE
K790083 · DQY
Namic
Cardiovascular · 13d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 349-01
K790098 · DXY
Intermedics, Inc.
Cardiovascular · 8d