FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77833–77856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2001
AUTO-LOCK
K010477 · MEG
Auto-Lock
General Hospital · 231d
Cleared Oct 09, 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · DQY
Concentric Medical, Inc.
Cardiovascular · 193d
Cleared Oct 09, 2001
LASER 20
K011021 · GEX
Ya-Man, Ltd.
General & Plastic Surgery · 188d
Cleared Oct 09, 2001
PHEM-ALERT
K012230 · LNW
Femtek,Llc.
Chemistry · 85d
Cleared Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · JIT
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Oct 09, 2001
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · EAT
Specialites Septodont
Dental · 70d
Cleared Oct 09, 2001
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER
K012485 · CAH
King Systems Corp.
General Hospital · 68d
Cleared Oct 09, 2001
MU PHOTONICS PAIN THERAPIST
K012508 · ILY
Nu Photonics, Inc.
Physical Medicine · 64d
Cleared Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION...
K012509 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 64d
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