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
118969–118992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1991
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · CIX
Technicon Instruments Corp.
Chemistry · 28d
Cleared Nov 27, 1991
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
K914906 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 26d
Cleared Nov 27, 1991
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
K914981 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1991
BELTONE PROFILE IN-THE-EAR HEARING AID
K914982 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Nov 25, 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
K913869 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 25, 1991
FLOSWITCH(R) HP
K913871 · DQO
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 22, 1991
SUPRAPUBIC FLOW CONTROLLER
K904798 · KOB
Olympus Corp.
Gastroenterology & Urology · 394d
Cleared Nov 22, 1991
TOWNLEY GREAT TOE JOINT
K911378 · KWD
Biopro, Inc.
Orthopedic · 239d
Cleared Nov 22, 1991
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
K911782 · FRN
Strato Medical Corp.
General Hospital · 214d
Cleared Nov 22, 1991
PHILIPS RIGID VOLUME COILS
K911872 · LNH
Philips Medical Systems, Inc.
Radiology · 210d
Cleared Nov 22, 1991
EASY ACCESS BED
K911893 · FNL
Willis Therapeutic Innovations, Inc.
General Hospital · 207d
Cleared Nov 22, 1991
MRH-500
K911993 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 199d
Cleared Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021 · HWC
Instrument Makar, Inc.
Orthopedic · 199d
Cleared Nov 22, 1991
UROTEST GPH
K912244 · JII
In Wha Pharmaceutical Co., Ltd.
Chemistry · 185d
Cleared Nov 22, 1991
ULTIMA XS, MODIFICATION
K912289 · GZJ
American Imex
Neurology · 183d
Cleared Nov 22, 1991
ALLERGY INFORMATION MANAGER
K912294 · DHB
Diagnostic Products Corp.
Immunology · 186d
Cleared Nov 22, 1991
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K912764 · GZB
Medtronic Vascular
Neurology · 151d
Cleared Nov 22, 1991
ITC GUIDING CATHETER
K913052 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 136d
Cleared Nov 22, 1991
3M IGE SINGLE POINT FAST TEST
K913212 · DHB
Whittaker Bioproducts, Inc.
Immunology · 126d
Cleared Nov 22, 1991
OSTEO BONE SCREWS
K913269 · HWC
Fred C. Bryson
Orthopedic · 122d
Cleared Nov 22, 1991
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
K913305 · GKZ
Unipath , Ltd.
Hematology · 120d
Cleared Nov 22, 1991
INCUBATOR 8000 IC
K913394 · FMZ
Dragerwerk AG
General Hospital · 115d
Cleared Nov 22, 1991
MEDTRONIC 3625 SCREENER SYSTEM
K913442 · GZB
Medtronic Vascular
Neurology · 112d
Cleared Nov 22, 1991
TX 3 TENS MODIFIED
K913532 · GZJ
Globalcare/Bay Medical Corp.
Neurology · 109d