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

Filters: Cleared only ×
176,076 results
170761–170784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056 · JSS
Vitek Systems, Inc.
Microbiology · 46d
Cleared Jan 26, 1979
MVS UNIT, MODEL SEU-8 AND DEU-8, 80
K782068 · EHZ
Dentsply Intl.
Dental · 44d
Cleared Jan 26, 1979
VENEER SYSTEM, MOSTIQUE LAMINATE
K782080 · KLE
Caulk Co., Div. Dentsply
Dental · 44d
Cleared Jan 26, 1979
INSTRUMENTS, OVERREFRACTION SYSTEM
K782096 · HLM
Zeiss Humphrey System
Ophthalmic · 39d
Cleared Jan 26, 1979
RIA KIT, GAMMACOAT
K782109 · CDX
Clinical Assays, Inc.
Chemistry · 38d
Cleared Jan 26, 1979
RIA KIT, RIANEN CORTISOL
K782110 · CGR
New England Nuclear
Chemistry · 38d
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