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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77185–77208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012792 · INI
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 65d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · LGZ
Nxstage Medical, Inc.
General Hospital · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 58d
Cleared Oct 24, 2001
XTERRA GT POWER WHEELCHAIR
K012909 · ITI
Invacare Corp.
Physical Medicine · 55d
Cleared Oct 24, 2001
COLLATEK POWDER
K012990 · KGN
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Oct 24, 2001
PASS SPINAL SYSTEM
K013191 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 288d
Cleared Oct 23, 2001
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
K011058 · DXN
Meridian Medical Technologies , Ltd.
Cardiovascular · 200d
Cleared Oct 23, 2001
ERO50, ORDER-NO.: 2070
K012838 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
EURO 45, ORDER-NO.: 2064
K012840 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 61d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · DXN
Health & Life Co., Ltd.
Cardiovascular · 43d
Cleared Oct 23, 2001
MODIFICATION TO BRAIDED GUIDING INTRODUCER
K013202 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 28d
Cleared Oct 23, 2001
POINT 4 FLOWABLE 2
K013325 · EBF
Kerr Dental Materials Center
Dental · 18d
Cleared Oct 22, 2001
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K011392 · MSS
Micra Instruments
Ophthalmic · 168d
Cleared Oct 22, 2001
CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM
K011502 · DZE
Crystal-Seal Dental Implants
Dental · 159d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · LDJ
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814 · DIO
Ameditech, Inc.
Toxicology · 133d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
K012453 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
K012457 · HBC
Sodemsystems
Neurology · 82d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d