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

Filters: Cleared only ×
175,820 results
149329–149352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1985
BROM CRESOL PURPLE STARCH
K851343 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
PURPLE BROTH
K851345 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
PHENYLALANINE AGAR
K851346 · JSH
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR
K851347 · JSJ
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 19, 1985
COBA AGAR
K851348 · JSJ
Micro Media Laboratories
Microbiology · 15d
Cleared Apr 18, 1985
AUSONICS 150
K843971 · IYO
Ausonics Pty , Ltd.
Radiology · 189d
Cleared Apr 18, 1985
AUSONICS 357
K843994 · IYO
Ausonics Pty , Ltd.
Radiology · 189d
Cleared Apr 18, 1985
COPAL DIGITAL SPHYGMOMAMOMETER UA-550
K844285 · DXN
Takeda Medical, Inc.
Cardiovascular · 164d
Cleared Apr 18, 1985
CORNEOMAP 4500
K844299 · IYO
Radionics Medical, Inc.
Radiology · 162d
Cleared Apr 18, 1985
BLOOD-PRESSURE ECG TRANSMITTER
K844310 · DXN
Instromedix, Inc.
Cardiovascular · 163d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
K844396 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
K844397 · DSK
Associated Mills, Inc.
Cardiovascular · 156d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795 · DXY
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812 · DXY
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
ND2100 SPINE SCANNER
K844835 · KGI
Nuclear Data, Inc.
Radiology · 127d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
TELEMANOMETER
K850166 · DRG
R.J. Ash, Medical Monitoring, Inc.
Cardiovascular · 92d
Cleared Apr 18, 1985
ULTRASOUND GEL
K850290 · IYO
Litton Datamedix
Radiology · 84d
Cleared Apr 18, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050
K850318 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 83d
Cleared Apr 18, 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 80d
Cleared Apr 18, 1985
NEONATAL MONITOR 309
K850407 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 18, 1985
AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL
K850678 · IZL
Fairchild Medical Systems, Inc.
Radiology · 56d