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
173785–173808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1977
ROOT CANAL FILES & REAMERS
K770367 · EKP
Cemco Tool Co., Inc.
Dental · 7d
Cleared Mar 01, 1977
ORAL IRRIGATOR
K770368
Clairol, Inc.
Dental · 6d
Cleared Mar 01, 1977
VACON TM
K770369 · CBD
Diemolding Corp.
General Hospital · 5d
Cleared Mar 01, 1977
FILTER, AIR, CUTTER MAINLINE
K770375 · CAH
Cutter Laboratories, Inc.
General Hospital · 4d
Cleared Mar 01, 1977
FILTER, NEBULIZER, CUTTER
K770376 · CAH
Cutter Laboratories, Inc.
General Hospital · 4d
Cleared Feb 28, 1977
MONITORING & STRESS TESTING EQUIPMENT
K760368 · DSI
Advanced Medical, Inc.
Cardiovascular · 208d
Cleared Feb 28, 1977
TUBE, GASTRO-ENTEROSTOMY
K760810 · EXD
Sherwood Medical Industries
Gastroenterology & Urology · 149d
Cleared Feb 28, 1977
HOUVA-LITE ARM UNIT #601
K761186 · FTC
National Biological Corp.
General & Plastic Surgery · 84d
Cleared Feb 28, 1977
HOUVA-LITE LEG UNIT #701
K761187 · FTC
National Biological Corp.
General & Plastic Surgery · 84d
Cleared Feb 28, 1977
HOUVA-LITE PALM UNIT #501
K761188 · FTC
National Biological Corp.
General & Plastic Surgery · 84d
Cleared Feb 28, 1977
HOUVA-LITE SOLE UNIT #502
K761189 · FTC
National Biological Corp.
General & Plastic Surgery · 84d
Cleared Feb 28, 1977
4 1/2 OZ. GRADUATED SPECIMEN CONTAINER
K761191 · FMH
Superior Plastic Products Corp.
General Hospital · 84d
Cleared Feb 28, 1977
DRESSING CHANGE KIT
K761192 · JOK
Superior Plastic Products Corp.
General Hospital · 84d
Cleared Feb 28, 1977
AIRWAY PRESSURE MONITOR
K761199 · GAP
Draeger Medical, Inc.
General & Plastic Surgery · 84d
Cleared Feb 28, 1977
HEMATRAK MATURITY PROFILE OPTION
K761208 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 83d
Cleared Feb 28, 1977
PORTAGAS AERATOR
K761341 · FLI
Amsco Co.
General Hospital · 62d
Cleared Feb 28, 1977
MONITOR, NEONATAL, MODEL 78261A
K770022 · DRT
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 28, 1977
MONITOR, NEONATE, MODEL 78213A
K770023 · DRT
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 28, 1977
MONITOR, NEONATAL, MODEL 78260A
K770024 · DRT
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 28, 1977
CASTLE TEC-TEST STEAM STERI. INTEGRATOR
K770078 · JOJ
Castle Co.
General Hospital · 46d
Cleared Feb 28, 1977
PLATELET CONTROL, NORMAL & ABNORMAL
K770095 · JPK
Bd Becton Dickinson Vacutainer...
Hematology · 42d
Cleared Feb 28, 1977
3-WAY STOPCOCK WITH LUER-LOCK FITTING
K770154 · KGZ
American Viggo
General & Plastic Surgery · 35d
Cleared Feb 28, 1977
MOTORIZED OPERATOR FOR PIPETTING DEV.
K770208 · JQW
Kensington Scientific
Microbiology · 28d
Cleared Feb 28, 1977
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
K770220 · KPS
G.D. Searle and Co.
Radiology · 25d