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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77329–77352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2001
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
K012518 · CJE
Thermo Dma, Inc.
Chemistry · 64d
Cleared Oct 09, 2001
CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
K012886 · HAW
Cbyon, Inc.
Neurology · 42d
Cleared Oct 09, 2001
ANIMEC, MODELS AM-2S-4 AND AM-2S-5
K012906 · LGZ
Elltec Co., Ltd.
General Hospital · 41d
Cleared Oct 09, 2001
ABI VEST AIRWAY CLEARANCE SYSTEM
K012928 · BYI
Advanced Respiratory
Anesthesiology · 39d
Cleared Oct 09, 2001
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
K013029 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Oct 09, 2001
MONARCH SPINAL SYSTEMS
K013294 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
TIMX SPINAL SYSTEMS
K013295 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 866d
Cleared Oct 05, 2001
ZEUS ROBOTIC SURGICAL SYSTEM
K003431 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 336d
Cleared Oct 05, 2001
SOCRATES ROBOTIC TELEMONITORING SYSTEM
K003661 · NEQ
Computer Motion, Inc.
General & Plastic Surgery · 311d
Cleared Oct 05, 2001
W & H ASSISTINA
K010127 · EFB
A-Dec, Inc.
Dental · 275d
Cleared Oct 05, 2001
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
K010706 · MNW
Measurement Specialties, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 05, 2001
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K011349 · DRC
Medcanica, Inc.
Cardiovascular · 156d
Cleared Oct 05, 2001
COM-PATCH
K012140 · GXY
Apex Medical Corp.
Neurology · 87d
Cleared Oct 05, 2001
SOPRO595 INTRA ORAL CAMERA
K012505 · EIA
Sopro
Dental · 63d
Cleared Oct 05, 2001
ALWAYS DUETS
K012629 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 53d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 05, 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · JEY
Inion , Ltd.
Dental · 25d
Cleared Oct 05, 2001
DIASUS
K013142 · IYO
Dynamic Imaging , Ltd.
Radiology · 15d
Cleared Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Oct 04, 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 387d
Cleared Oct 04, 2001
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
K004001 · DTZ
Dideco
Cardiovascular · 282d