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
160801–160824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1982
SABOURAUD DEXTROSE AGAR
K820561 · JSJ
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
CAMPYLOBACTER SELECTIVE MEDIUM
K820562 · JSJ
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
ESP SERIES (X-RAY GENERATORS
K820593 · IZO
Xonics Medical Systems, Inc.
Radiology · 15d
Cleared Mar 19, 1982
HOT & COLD PULP TESTER #4001
K820598 · EAT
Analytic Technology
Dental · 15d
Cleared Mar 19, 1982
NASAL INSTRUMENTS
K820621 · EQH
Applied Fiberoptics, Inc.
Ear, Nose, Throat · 11d
Cleared Mar 19, 1982
A CALIPER
K820659 · KTZ
Twin City Surgical, Inc.
Orthopedic · 9d
Cleared Mar 19, 1982
A HOOK DRIVER
K820660 · KWP
Twin City Surgical, Inc.
Orthopedic · 9d
Cleared Mar 19, 1982
DISPOSABLE ELECTRODE
K820664 · HAM
Trident Surgical Corp.
General & Plastic Surgery · 8d
Cleared Mar 18, 1982
STOCKERT CARDIAC PACING ELECTRODES
K812049 · DTB
Stoeckert Instrumente
Cardiovascular · 240d
Cleared Mar 18, 1982
DERMAFILE (CAT. # 38
K813360 · KKX
Exco, Inc.
General Hospital · 108d
Cleared Mar 18, 1982
TAMPAX TAMPONS
K820174 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 56d
Cleared Mar 18, 1982
IV ALERT SYSTEM
K820200 · KPE
Allied Medical Technologies, Inc.
General Hospital · 51d
Cleared Mar 18, 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356 · DXY
Cordis Corp.
Cardiovascular · 38d
Cleared Mar 18, 1982
VENES CUSTON RX
K820484 · FQL
Jung Products, Inc.
General Hospital · 24d
Cleared Mar 18, 1982
STERILIZATION WRAP
K820521 · FRG
General Medical Co.
General Hospital · 20d
Cleared Mar 18, 1982
ANESTHESIA EXTENSION TUBES
K820527 · FPK
David Simmonds Co., Inc.
General Hospital · 17d
Cleared Mar 18, 1982
IVAC #1160 MULTIPLE VITAL SIGNS UNIT
K820569 · DXN
Y
Cardiovascular · 16d
Cleared Mar 18, 1982
MAINFLOW BACTERIA FILTER
K820576 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Mar 18, 1982
ANESTHESIA BACTERIA FILTER
K820577 · CAH
Omnicon Medical Corp.
General Hospital · 15d
Cleared Mar 18, 1982
NORTON JUGULAR KITS
K820581 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Mar 18, 1982
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · KME
3M Company
General Hospital · 14d
Cleared Mar 16, 1982
MICROMEDIC SYSTEMS ISOFLEX
K820376 · JJJ
Micromedic Systems
Radiology · 35d
Cleared Mar 16, 1982
PLATELET AGGREGOMETERS
K820422 · GHR
Chrono-Log Corp.
Hematology · 28d
Cleared Mar 16, 1982
IV START TRAY
K820490 · LRS
Seamless Hospital Products Co.
General & Plastic Surgery · 21d