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
44161–44184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2012
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
K121064 · OLO
Mako Surgical Corporation
Orthopedic · 61d
Cleared Jun 06, 2012
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
K121094 · LJS
Medical Components, Inc.
General Hospital · 57d
Cleared Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 54d
Cleared Jun 06, 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · DZE
Straumann USA
Dental · 54d
Cleared Jun 06, 2012
PROSOFT
K121318 · EBP
Perma Laboratories
Dental · 35d
Cleared Jun 06, 2012
ARIATELE TELEMETRY TRANSMITTER (96281)
K121480 · MHX
Spacelabs Healthcare
Cardiovascular · 19d
Cleared Jun 06, 2012
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · GEH
AtriCure, Inc.
General & Plastic Surgery · 16d
Cleared Jun 05, 2012
HEALEX BIOSPONGE WOUND DRESSING
K112191 · KGN
Bionova Medical, Inc.
General & Plastic Surgery · 312d
Cleared Jun 05, 2012
CITIEFFE-TITANIUM CANNULATED SCREW
K113388 · HWC
Citieffe
Orthopedic · 202d
Cleared CT Jun 05, 2012
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 172d
Cleared Jun 05, 2012
HOMOCYSTEINE TEST
K113793 · LPS
Roche
Chemistry · 165d
Cleared Jun 05, 2012
ULTIMA NEO
K120054 · GZJ
Pain Management Technologies
Neurology · 151d
Cleared Jun 05, 2012
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
K120303 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 125d
Cleared Jun 05, 2012
BRAIN PORT
K120691 · GZT
Nico Corporation
Neurology · 90d
Cleared Jun 05, 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER,...
K120759 · CGA
I-Sens, Inc.
Chemistry · 84d
Cleared Jun 05, 2012
CENTRICITY PACS-IW
K121387 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 28d
Cleared Jun 05, 2012
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
K121515 · ONF
Solta Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jun 04, 2012
SNORKEL
K112766 · LQZ
Fellmar Company
Dental · 256d
Cleared Jun 04, 2012
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
K120370 · OQG
Zimmer, Inc.
Orthopedic · 119d
Cleared Jun 04, 2012
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435 · JOJ
STERIS Corporation
General Hospital · 112d
Cleared Jun 04, 2012
MACH BRACKETS BRIGHT BRACKETS
K120471 · NJM
World Bio Tech Co., Ltd.
Dental · 109d
Cleared Jun 04, 2012
S-250 PROTON BEAM RADIATION THERAPY SYSTEM
K120676 · LHN
Mevion Medical Systems
Radiology · 91d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · HRS
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Jun 04, 2012
LIGHT FOR WRINKLES
K120775 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 82d