Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
138721–138744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1987
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133
K873722 · LGF
Martin Medical
Orthopedic · 17d
Cleared Oct 02, 1987
CIPRO SENSITIVITY DISKS
K873829 · JTN
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Oct 01, 1987
SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
K871964 · GWF
Siegen Corp.
Neurology · 134d
Cleared Oct 01, 1987
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 99d
Cleared Oct 01, 1987
MDS-90 ARGON DYE LASER FOR DERMATOLOGY
K872578 · GEX
Meditec of America
General & Plastic Surgery · 93d
Cleared Oct 01, 1987
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K872732 · JDI
Dow Corning Wright
Orthopedic · 85d
Cleared Oct 01, 1987
MYOSTIM(TM), MODEL 6600
K872753 · IPF
Medical Devices, Inc.
Physical Medicine · 80d
Cleared Oct 01, 1987
SAMUELSON ACETABULAR CUP
K872985 · KWA
Protek, Inc.
Orthopedic · 62d
Cleared Oct 01, 1987
KIRSCHNER NEER-III PROXIMAL HUMERUS
K873073 · HSD
Kirschner Medical Corp.
Orthopedic · 56d
Cleared Oct 01, 1987
HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES
K873742 · NWA
Hood Laboratories
General & Plastic Surgery · 15d
Cleared Sep 30, 1987
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · GWL
Nihon Kohden America, Inc.
Neurology · 216d
Cleared Sep 30, 1987
MODIFIED RADIUS - MODEL NUMBER MM 5000
K871727 · JOP
Ultrasonix, Inc.
Cardiovascular · 155d
Cleared Sep 30, 1987
CHURCHILL INTER-CARDIAC SUCKER
K872043 · DWF
Churchill Corp.
Cardiovascular · 126d
Cleared Sep 30, 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · DPW
Advanced Technology Laboratories, Inc.
Cardiovascular · 124d
Cleared Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 117d
Cleared Sep 30, 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 111d
Cleared Sep 30, 1987
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346 · GTZ
Medix Biotech, Inc.
Microbiology · 105d
Cleared Sep 30, 1987
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · DRS
American Edwards Laboratories
Cardiovascular · 90d
Cleared Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 85d
Cleared Sep 30, 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · DTN
Shiley, Inc.
Cardiovascular · 82d
Cleared Sep 30, 1987
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
K873157 · HKI
Holofax , Ltd.
Ophthalmic · 51d
Cleared Sep 30, 1987
URETERAL BULB DILATORS
K873178 · EZN
Penn Medical Devices, Inc.
Gastroenterology & Urology · 49d
Cleared Sep 30, 1987
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
K873206 · DTW
Respiratory Support Products, Inc.
Cardiovascular · 47d
Cleared Sep 30, 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · DYB
Quinton, Inc.
Cardiovascular · 37d