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
167929–167952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1979
1 STEP
K792003 · DYH
Betta Dental, Inc.
Dental · 55d
Cleared Nov 27, 1979
CORDIA RF
K792061 · DHR
Cordis Corp.
Immunology · 43d
Cleared Nov 27, 1979
CHRONAEROBIC (CA-1)
K792122 · DRT
Stanford Scientific, Inc.
Cardiovascular · 33d
Cleared Nov 27, 1979
CO 2 METER
K792155 · CCK
Boehringer Laboratories
Anesthesiology · 34d
Cleared Nov 27, 1979
FISCH DRILL SYSTEM
K792159 · ERL
Jedmed Instrument Co.
Ear, Nose, Throat · 29d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · CDX
Abbott Laboratories
Immunology · 27d
Cleared Nov 27, 1979
SERIES S (BEHIND-THE-EAR-HEARING AID)
K792198 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 27, 1979
UNIFOCAL 2-UNIPOLAR & BIPOLAR
K792199 · DXY
American Pacemaker Corp.
Cardiovascular · 26d
Cleared Nov 27, 1979
DURAZYME GOT/AST
K792208 · CIT
American Monitor Corp.
Chemistry · 25d
Cleared Nov 27, 1979
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214 · BWF
Starkey Laboratories, Inc.
Anesthesiology · 25d
Cleared Nov 27, 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · BWF
Airlife, Inc.
Anesthesiology · 22d
Cleared Nov 27, 1979
MISTY BEBULIZER
K792218 · CAF
Airlife, Inc.
Anesthesiology · 22d
Cleared Nov 27, 1979
UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR
K792232 · DXY
American Pacemaker Corp.
Cardiovascular · 22d
Cleared Nov 27, 1979
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234 · CDT
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Nov 27, 1979
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · BSK
Shiley, Inc.
Anesthesiology · 18d
Cleared Nov 27, 1979
CIRCAPAK
K792268 · BZO
Respiratory Care, Inc.
Anesthesiology · 18d
Cleared Nov 27, 1979
USHER'S MARLEX TUBULAR MESH
K792281 · FTL
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Nov 27, 1979
LS-100
K792302 · EFB
Midwest
Dental · 11d
Cleared Nov 27, 1979
MW 8000-I
K792303 · EBF
Midwest
Dental · 11d
Cleared Nov 27, 1979
MW-8000
K792304 · EFB
Midwest
Dental · 11d
Cleared Nov 27, 1979
A.D.E. ASPEN DISPERSIVE ELECTRODE
K792315 · GEI
Zimmer, Inc.
General & Plastic Surgery · 11d
Cleared Nov 21, 1979
ROCHE SENSOR ADAPTOR
K791559 · KLK
Roche Medical Electronics, Inc.
Anesthesiology · 96d
Cleared Nov 21, 1979
SARNS MEDIASTINAL AND PERICARDIAL TUBE
K792070 · DWF
3M Health Care, Sarns
Cardiovascular · 37d
Cleared Nov 21, 1979
MODEL CF-300 THREE CHANNEL FLOW METER
K792190 · DRQ
Wilton Webster Laboratories
Cardiovascular · 21d