FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
127177–127200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · JHI
Bd Becton Dickinson Vacutainer...
Toxicology · 23d
Cleared Mar 29, 1990
ELITECH GAMMA GT TEST KIT
K901090 · JPZ
Elite Technology, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
K901113 · JIS
Verichem Laboratories, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122 · CFR
Technicon Instruments Corp.
Chemistry · 17d
Cleared Mar 29, 1990
COULTER MAGNESIUM REAGENT
K901265 · JGJ
Coulter Corp.
Chemistry · 13d
Cleared Mar 28, 1990
POLYSTAN HEART-LUNG MACHINE SYSTEM
K894657 · DJQ
Polystan C/O Vitalcor, Inc.
Toxicology · 247d
Cleared Mar 28, 1990
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · DQR
Shiley, Inc.
Cardiovascular · 247d
Cleared Mar 28, 1990
OSSEODENT(R) PRECISION DENTAL ATTACHMENTS
K895463 · DZE
Collagen Corp.
Dental · 203d
Cleared Mar 28, 1990
OXYMAX
K895791 · BZL
Columbus Instruments Intl. Corp.
Anesthesiology · 181d
Cleared Mar 28, 1990
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
K896118 · HET
American Surgical Instruments Corp.
Obstetrics & Gynecology · 156d
Cleared Mar 28, 1990
PLAK TRAC POWERED TOOTHBRUSH
K896245 · JEQ
Windmere Corp.
Dental · 149d
Cleared Mar 28, 1990
CORDIS SHUTTLE CATHETER
K896308 · DQO
Cordis Corp.
Cardiovascular · 147d
Cleared Mar 28, 1990
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · LZU
Look, Inc.
Ophthalmic · 90d
Cleared Mar 28, 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · BYE
Respironics, Inc.
Anesthesiology · 78d
Cleared Mar 28, 1990
MODIFIED SEISMOCARDIOGRAPH
K900130 · DSB
Seismed Instruments, Inc.
Cardiovascular · 82d
Cleared Mar 28, 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
K900132 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 77d
Cleared Mar 28, 1990
MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
K900291 · CCK
F.L.W. Plastics, Inc.
Anesthesiology · 65d
Cleared Mar 28, 1990
HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
K900339 · DTS
Shiley, Inc.
Cardiovascular · 64d
Cleared Mar 28, 1990
PROTEMP II
K900436 · EBG
Espe GmbH (Us)
Dental · 57d
Cleared Mar 28, 1990
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
K900601 · KFM
3M Company
Cardiovascular · 48d
Cleared Mar 28, 1990
FLUORESCENT T12 UVA LAMP
K900649 · FTC
Light Sources, Inc.
General & Plastic Surgery · 47d
Cleared Mar 28, 1990
OXIMAX 100
K900843 · DQA
Pace Tech, Inc.
Anesthesiology · 34d
Cleared Mar 28, 1990
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · IZH
Fischer Imaging Corp.
Radiology · 26d