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
149665–149688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1985
CENTURY SCALE
K844872 · FNG
Century Manufacturing Co.
General Hospital · 53d
Cleared Feb 08, 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
CARDIOBEEPER PROFILE MONITOR
K844966 · DXH
Survival Technology, Inc.
Cardiovascular · 46d
Cleared Feb 08, 1985
ELECTROCARDIOGRAPH-ECG CALIPER
K850021 · DPS
Devcom, Inc.
Cardiovascular · 36d
Cleared Feb 08, 1985
COLTENE PRECISE
K850036 · ELW
Coltene, Inc.
Dental · 32d
Cleared Feb 08, 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043 · DRT
Del Mar Avionics
Cardiovascular · 32d
Cleared Feb 08, 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · EBD
Johnson & Johnson Professionals, Inc.
Dental · 30d
Cleared Feb 08, 1985
GDC-1629 A CASTING ALLOY
K850101 · EJS
Deringer-Ney, Inc.
Dental · 28d
Cleared Feb 08, 1985
GDC-1433 A CASTING ALLOY
K850102 · EJS
Deringer-Ney, Inc.
Dental · 28d
Cleared Feb 08, 1985
GDC-1489 A CASTING ALLOY
K850103 · EJS
Deringer-Ney, Inc.
Dental · 28d
Cleared Feb 08, 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113 · DRT
Gould, Inc.
Cardiovascular · 25d
Cleared Feb 08, 1985
PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)
K850193 · EJS
Degussa Dental, Inc.
Dental · 21d
Cleared Feb 07, 1985
QUIKPAGE ARRHYTHMIA REPORT GENERATOR
K841083 · DSI
Agilent Technologies
Cardiovascular · 331d
Cleared Feb 07, 1985
BIOTRONIK DNP UNIPOLAR
K841450 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
BIOTRONIK DY-UNIPOLAR
K841451 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
DONWAY SPLINT
K843522 · ITH
Australian Biomedical Corporation , Ltd.
Physical Medicine · 153d
Cleared Feb 07, 1985
FLUOROSCAN/TM BY HEALTHMATE
K843920 · JAA
Healthmate, Inc.
Radiology · 125d
Cleared Feb 07, 1985
SYNATOMIC STANDARD TIBIAL PLATEAU
K844355 · HSX
Depuy, Inc.
Orthopedic · 90d
Cleared Feb 07, 1985
SOLEO SUNBED
K844788
Hapro International B.V.
General & Plastic Surgery · 59d
Cleared Feb 07, 1985
TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE
K844917 · FPA
Turn Needle Intl., Inc.
General Hospital · 50d
Cleared Feb 07, 1985
ORIGINAL REGULAR TAMPAX TAMPONS
K844935 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 50d
Cleared Feb 07, 1985
SUPER TAMPAX TAMPONS
K844936 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 50d
Cleared Feb 07, 1985
EPICHROME PAP
K844968 · JFH
Cetus Corp.
Chemistry · 45d