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
87553–87576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K983894 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 15d
Cleared Nov 18, 1998
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
K983971 · JJX
Diagnostic Products Corp.
Chemistry · 9d
Cleared Nov 17, 1998
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
K980492 · FFK
Circon Acmi
Gastroenterology & Urology · 281d
Cleared Nov 17, 1998
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K980551 · BZD
Nidek Medical Products, Inc.
Anesthesiology · 278d
Cleared Nov 17, 1998
BONE INJECTION GUN (B.I.G.) DEVICE
K981853 · FMI
Waismed, Ltd.
General Hospital · 175d
Cleared Nov 17, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K982168 · LPN
Ciba Vision Corporation
Ophthalmic · 151d
Cleared Nov 17, 1998
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
K983046 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 77d
Cleared Nov 17, 1998
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH...
K983048 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 77d
Cleared Nov 17, 1998
EPIDURAL CATHETER MODELS 1210/1200
K983125 · CAZ
Rusch Intl.
Anesthesiology · 70d
Cleared Nov 17, 1998
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
K983855 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Nov 16, 1998
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K980045 · DSI
Invivo Research, Inc.
Cardiovascular · 314d
Cleared Nov 16, 1998
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K980182 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 300d
Cleared Nov 16, 1998
OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT...
K982610 · ITX
Olympus Optical, Co.
Radiology · 112d
Cleared Nov 16, 1998
FORTE
K982911 · KPS
Adac Laboratories
Radiology · 90d
Cleared Nov 16, 1998
DUREX SENSIDOM LATEX CONDOM
K982924 · HIS
London Intl., LLC
Obstetrics & Gynecology · 88d
Cleared Nov 16, 1998
SIGNA PROFILE SMALL HEAD COIL
K982972 · MOS
GE Medical Systems
Radiology · 83d
Cleared Nov 16, 1998
SKULL BASE INSTATRAK SYSTEM
K982994 · LLZ
Visualization Technology, Inc.
Radiology · 81d
Cleared Nov 16, 1998
XRAY VISION
K983111 · LLZ
Apteryx, Inc.
Radiology · 73d
Cleared Nov 16, 1998
MARK 5000 PHASED ARRAY SHOULDER COIL
K983143 · MOS
Usa Instruments, Inc.
Radiology · 69d
Cleared Nov 16, 1998
CYTOPREP
K983181 · HHI
Cytoprep Inc. Est.
Obstetrics & Gynecology · 66d
Cleared Nov 16, 1998
DUREX LUBRAGEL LATEX CONDOM
K983380 · HIS
London Intl., LLC
Obstetrics & Gynecology · 52d
Cleared Nov 16, 1998
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · HHT
Andwin Scientific
Obstetrics & Gynecology · 48d
Cleared Nov 16, 1998
25-HYDROXYVITAMIN D 125I RIA KIT
K983617 · LCI
DiaSorin, Inc.
Chemistry · 32d
Cleared Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659 · IZH
Planmed OY
Radiology · 28d