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
57289–57312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2008
PRIMAEVA MEDICAL SYSTEM
K080145 · GEI
Primaeva Medical, Inc.
General & Plastic Surgery · 37d
Cleared Feb 28, 2008
MODIFICATION TO:NESS L300
K080219 · GZI
Ness-Neuromuscular Electrical...
Neurology · 30d
Cleared Feb 27, 2008
SOCT COPERNICUS, MODEL 15205
K071839 · OBO
Reichert, Inc.
Ophthalmic · 237d
Cleared Feb 27, 2008
15W CERALAS D 1470NM DIODE LASER
K073063 · GEX
Biolitec, Inc.
General & Plastic Surgery · 120d
Cleared Feb 27, 2008
APEX-LNK POLY ACETABULAR CUP LINERS
K073150 · LPH
Omni Life Science, Inc.
Orthopedic · 111d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 99d
Cleared Feb 27, 2008
EI DOWNPAK BARRIER SLEEVES
K073369 · EKM
Hu-Friedy Mfg. Co., Inc.
Dental · 89d
Cleared Feb 27, 2008
VENA CAVA FILTER
K073528 · DTK
Cook Incorporated
Cardiovascular · 72d
Cleared Feb 27, 2008
GUARDIAN HEMOSTASIS VALVE
K073620 · DTL
Zerusa Limited
Cardiovascular · 63d
Cleared Feb 27, 2008
C.T.M. POWER CHAIR, MODEL HS-1500
K073686 · ITI
C.T.M. Homecare Product, Inc.
Physical Medicine · 61d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147 · JJX
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Feb 27, 2008
HEARTWAY POWER MOBILITY SCOOTER, PF7
K080242 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 27d
Cleared Feb 27, 2008
QUIKCLOT NOSEBLEED
K080247 · LYA
Z-Medica Corporation
General & Plastic Surgery · 27d
Cleared Feb 27, 2008
CHARLOTTE CLAW 3.5
K080295 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Feb 26, 2008
LAVA FRAME, LAVA FRAME SHADE
K072055 · NHA
3M Espe AG Dental Products
Dental · 215d
Cleared Feb 26, 2008
MEDICAL GLOVE SERIES
K072145 · LYY
Zhanjiang Jiali Glove Products Co., Ltd.
General Hospital · 208d
Cleared Feb 26, 2008
PHILIPS HEARTSTART SMARTPADS III
K072812 · MKJ
Philips Medical Systems
Cardiovascular · 148d
Cleared Feb 26, 2008
CARDIQ EXPRESS VERSION 2.0
K073138 · JAK
GE Medical Systems
Radiology · 111d
Cleared Feb 26, 2008
CARDIQ FUNCTION XPRESS
K073153 · JAK
GE Medical Systems SCS
Radiology · 110d
Cleared Feb 26, 2008
CELLSEARCH CIRCULATING TUMOR CELL KIT
K073338 · NQI
Veridex, LLC
Pathology · 90d
Cleared Feb 26, 2008
MICRUS MICROCOIL SYSTEMS
K073442 · HCG
Micrus Endovascular Corporation
Neurology · 81d
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION...
K073561 · CFN
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 26, 2008
MANDREL GUIDEWIRES OR M-WIRES
K080144 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 35d
Cleared Feb 26, 2008
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · DXC
Radi Medical Systems AB
Cardiovascular · 29d