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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78433–78456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d
Cleared Oct 10, 2001
SNOWPOST, SNOWLIGHT
K012354 · ELR
Danville Materials, Inc.
Dental · 77d
Cleared Oct 10, 2001
HELIX HYDRO-JET
K012464 · FQH
Andreas Pein Medizintechnik GmbH
General Hospital · 70d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · JDC
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 10, 2001
RHODIA DENTAL PUTTY IMPRESSION MATERIAL
K013129 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
K013140 · ELW
Rhodia, Inc.
Dental · 21d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · JHI
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Cook, Inc.
Anesthesiology · 280d
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