FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88057–88080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1998
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME...
K983425 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME...
K983426 · LLL
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
PROCERA ALLCERAM FUSING MATERIAL
K983453 · EIH
Nobel Biocare Uas, Inc.
Dental · 49d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME...
K983464 · LLL
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME...
K983465 · LKO
Zeus Scientific, Inc.
Immunology · 48d
Cleared Nov 18, 1998
QUADRANT UNIBOND
K983545 · KLE
Cavex Holland BV
Dental · 40d
Cleared Nov 18, 1998
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · HAW
Radionics, Inc.
Neurology · 30d
Cleared Nov 18, 1998
IS-ANTI-PR3 IGG ELISA TEST SYSTEM
K983740 · MOB
Columbia Bioscience, Inc.
Immunology · 27d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850 · JIT
Dade Behring, Inc.
Chemistry · 19d
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