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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
39169–39192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Jan 23, 2014
KHAN KINETIC TREATMENT (KKT-M2)
K130666 · LXM
Optima Health Solutions International...
Physical Medicine · 317d
Cleared Jan 23, 2014
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131490 · HSB
Ellipse Technologies, Inc.
Orthopedic · 245d
Cleared Jan 23, 2014
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
K131580 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 237d
Cleared Jan 23, 2014
JUVORA DENTQAL DISC
K132725 · EBI
Juvora
Dental · 146d
Cleared Jan 23, 2014
ZYNO MEDICAL ADMINISTRATION SET
K132841 · FPA
Zyno Medical, LLC
General Hospital · 135d
Cleared Jan 23, 2014
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
K132928 · DXT
Medrad, Inc. / Bayer Medical Care, Inc.
Cardiovascular · 127d
Cleared Jan 23, 2014
SPEED 808 DIODE LASER SYSTEM
K132989 · GEX
Beijing Toplaser Technology Co., Ltd.
General & Plastic Surgery · 121d
Cleared Jan 23, 2014
GRINDGUARD
K133037 · OBR
Grind Guard Technologies, LLC
Dental · 119d
Cleared Jan 23, 2014
CAREFINE PEN NEEDLE
K133100 · FMI
Facet Technologies
General Hospital · 115d
Cleared Jan 23, 2014
MAC 2000 ECG ANALYSIS SYSTEM
K133622 · DPS
Wipro GE Healthcare
Cardiovascular · 62d
Cleared Jan 23, 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675 · HRS
Aap Implantate AG
Orthopedic · 55d
Cleared Jan 22, 2014
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613 · HWC
Laura Cattabriga
Orthopedic · 321d
Cleared Jan 22, 2014
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER...
K131135 · MBB
Biomet Manufacturing Corp
Orthopedic · 275d
Cleared Jan 22, 2014
ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
K131644 · NHA
Dentsply International, Inc.
Dental · 231d
Cleared Jan 22, 2014
CO2 FRACTIONAL LASER
K131837 · GEX
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 216d
Cleared Jan 22, 2014
KESTREL POSTERIOR CERVICAL SPINE SYSTEM
K132122 · KWP
Omni Surgical, LLC Dba Spine360
Orthopedic · 196d
Cleared Jan 22, 2014
HYPERION LONG PULSED ND: YAG LASER
K132286 · GEX
Scarlet Rf, Inc.
General & Plastic Surgery · 183d
Cleared Jan 22, 2014
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
K132421 · MAX
Aesculap Implant Systems, Inc.
Orthopedic · 170d
Cleared Jan 22, 2014
EDS ULTRASONIC TIPS
K132609 · ELC
Essential Dental Systems, Inc.
Dental · 155d
Cleared Jan 22, 2014
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · GJS
Instrumentation Laboratory CO
Hematology · 145d
Cleared Jan 22, 2014
MPACT EXTENSION
K132879 · LPH
Medacta International
Orthopedic · 131d
Cleared Jan 22, 2014
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
K133030 · LLZ
Invivo Corporation
Radiology · 118d
Cleared Jan 22, 2014
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
K133152 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 61d