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
118321–118344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1992
GRIESHABER AIR/FLUID TUBING SET
K914587 · KYG
Grieshaber & Co.
Ophthalmic · 99d
Cleared Jan 23, 1992
LEKSELL GAMMAPLAN (LGP)
K914808 · IWB
Elekta Instruments, Inc.
Radiology · 90d
Cleared Jan 23, 1992
ELISA TOXO IGM
K914852 · LGD
Sclavo, Inc.
Microbiology · 87d
Cleared Jan 23, 1992
FRIEDMANN ANALYSER 3
K914896 · HOK
Clement Clarke, Inc.
Ophthalmic · 84d
Cleared Jan 23, 1992
STORZ IMAGING SYSTEM
K915199 · IZI
Fischer Imaging Corp.
Radiology · 65d
Cleared Jan 23, 1992
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 64d
Cleared Jan 23, 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · FST
Pentax Precision Instrument Corp.
General & Plastic Surgery · 59d
Cleared Jan 23, 1992
SUCTION/IRRIGATION CANNULA
K915298 · GCJ
Lifeguard Medical Products, Inc.
General & Plastic Surgery · 69d
Cleared Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
K915395 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · GGW
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jan 23, 1992
URIHESIVE STRIP
K915616 · EXI
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 38d
Cleared Jan 23, 1992
PHILIPS M60 SERIES
K920142 · ESD
Philips Int'L B.V.
Ear, Nose, Throat · 10d
Cleared Jan 22, 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · KWP
Danek Medical, Inc.
Orthopedic · 495d
Cleared Jan 22, 1992
OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630
K911722 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 280d
Cleared Jan 22, 1992
DERMA-LASE RUBY LASER - MODEL DLR-1
K913256 · GEX
Derma-Lase Co.
General & Plastic Surgery · 190d
Cleared Jan 22, 1992
SONIX...THERAPEUTIC SONIC MASSAGE
K913439 · IRO
Mcshirley Products, Inc.
Physical Medicine · 173d
Cleared Jan 22, 1992
MEDTRONIC MODEL 3586 RESUME LEAD
K913934 · GZB
Medtronic Vascular
Neurology · 141d
Cleared Jan 22, 1992
ENDOSCOPES
K914084 · GCJ
Precise Optics
General & Plastic Surgery · 140d
Cleared Jan 22, 1992
ANGIOGRAPHIC FLUSH SYSTEM
K914113 · FPA
E-Z-Em, Inc.
General Hospital · 131d
Cleared Jan 22, 1992
IL TEST(TM) CALIBRATION SET SP
K914909 · JIX
Instrumentation Laboratory CO
Chemistry · 82d
Cleared Jan 22, 1992
MICROLINE SCREEN FOR CANNABINOID
K914915 · LDJ
Drug Screening Systems, Inc.
Toxicology · 79d
Cleared Jan 22, 1992
OPIATE EIA ASSAY
K915180 · DJG
Diagnostic Reagents, Inc.
Toxicology · 68d
Cleared Jan 22, 1992
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K915231 · FRN
Q-Life Systems, Inc.
General Hospital · 61d
Cleared Jan 22, 1992
STACKING MICROPLATE WASHER
K915284 · JQW
Denley Instruments, Inc.
Chemistry · 58d