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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165745–165768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1980
CUFFED TRACHEA TUBE FOR USE W/PERTRACH
K801379 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 90d
Cleared Sep 09, 1980
ASSURE LEVEL I PROD. #30171
K801538 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ASSURE LEVEL II PROD. #30172
K801539 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ORTHO AUTOMATED CELL COUNTER
K801545 · GKL
Ortho Instruments
Hematology · 64d
Cleared Sep 09, 1980
TEST PANEL FOR PRESUMP. ID/BACT. ORG
K801547 · JSP
Micro-Media Systems, Inc.
Microbiology · 64d
Cleared Sep 09, 1980
SAPCRILL THERMODETECT BREAST SCANNER DEV
K801573 · KYZ
California Cardiac Systems, Inc.
General Hospital · 62d
Cleared Sep 09, 1980
ACE FISCHER EXTERNAL FIXATION DEVICE
K801594 · HXK
Ace Orthopedic Manufacturing Co.
Orthopedic · 57d
Cleared Sep 09, 1980
VASCULAR GRAFT PROSTH. OF EXP. MICRO.
K801621 · DSY
Impra, Inc.
Cardiovascular · 56d
Cleared Sep 09, 1980
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
K801659 · HJO
Coburn Optical Ind., Inc.
Ophthalmic · 50d
Cleared Sep 09, 1980
SUR-FIT SYSTEM STERILE O.R. SETS
K801703 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 09, 1980
HDL CHOLESTEROL TEST KIT
K801726 · LBS
Mallinckrodt Critical Care
Chemistry · 47d
Cleared Sep 09, 1980
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727 · CDL
Data Medical Associates, Inc.
Chemistry · 47d
Cleared Sep 09, 1980
FIELD-LEE BRAIN BIOPSY NEEDLE
K801760 · HAO
American V. Mueller
Neurology · 43d
Cleared Sep 09, 1980
EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
K801806 · DXY
Arco Medical Products Co.
Cardiovascular · 41d
Cleared Sep 09, 1980
PALPATION ENHANCER
K801811 · LDE
Medical Horizons Co.
Cardiovascular · 63d
Cleared Sep 09, 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · DSI
Del Mar Avionics
Cardiovascular · 39d
Cleared Sep 09, 1980
SURGICAL BANDAGES/SUNLEEP DX
K801840 · NAD
Martin'S Maine Exchange
General & Plastic Surgery · 39d
Cleared Sep 09, 1980
ELECTROCARDIOGRAPH ELECTRODE
K801846 · DRX
Phoenix Glove Co.
Cardiovascular · 36d
Cleared Sep 09, 1980
CAM-10 RESPIRATORY HOSE ASSEMBLIES
K801859 · BZO
Lifecare Services, Inc.
Anesthesiology · 35d
Cleared Sep 09, 1980
PEEP FACE MASK
K801883 · BYG
Vital Signs, Inc.
Anesthesiology · 33d
Cleared Sep 09, 1980
HANCOCK * OBTURATORS
K801885 · DTI
Hancock Laboratories, Inc.
Cardiovascular · 33d
Cleared Sep 09, 1980
LIFE CERVICAL ADJUSTING MACHINE
K801900
Life Chiropractic College, Inc.
Physical Medicine · 32d
Cleared Sep 09, 1980
INSULATING SHEATH
K801910 · DXY
Cordis Corp.
Cardiovascular · 29d
Cleared Sep 09, 1980
HI-LO TEMP GEN. PURPOSE TEMP. PROBE
K801924 · FLL
National Catheter Co. Div. Mallinckrodt
General Hospital · 28d