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

Filters: Cleared only ×
175,820 results
46009–46032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2011
ENSEAL G2 TISSUS SEALERS
K112033 · GEI
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 116d
Cleared Nov 08, 2011
CALIX PC SPINAL IMPLANT SYSTEM
K112036 · ODP
X-Spine Systems, Inc.
Orthopedic · 113d
Cleared Nov 08, 2011
FIBER DISK AND BLOCK
K112186 · EBG
Bioloren S.R.L.
Dental · 102d
Cleared Nov 08, 2011
PROW FUSION
K112359 · MAX
Nlt Spine, Ltd.
Orthopedic · 84d
Cleared Nov 08, 2011
GRANDIO CORE DUAL CURE
K112447 · EBF
Voco GmbH
Dental · 75d
Cleared Nov 08, 2011
HI-TORQUE POWERTURN
K112957 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 35d
Cleared Nov 08, 2011
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
K113129 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 15d
Cleared Nov 07, 2011
IT/IF CONTROL
K101863 · JJY
Sebia
Immunology · 493d
Cleared Nov 07, 2011
NUFACE PLUS
K103472 · NFO
Carol Cole Company
Neurology · 348d
Cleared Nov 07, 2011
LAMINAR FLOW PHACO TIPS
K111882 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 129d
Cleared Nov 07, 2011
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K112068 · OVE
Synthes Spine Co.Lp
Orthopedic · 110d
Cleared Nov 07, 2011
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
K112145 · LLZ
Totoku Electric Co., Ltd.
Radiology · 104d
Cleared Nov 07, 2011
S6 DIAGNOSTIC ULTRASOUND SYSTEM
K112602 · IYN
Sonoscape Company Limited
Radiology · 61d
Cleared Nov 04, 2011
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
K100811 · OBH
ImpediMed Limited
Gastroenterology & Urology · 592d
Cleared Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103021 · NBW
Infopia Co, Ltd.
Chemistry · 388d
Cleared Nov 04, 2011
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
K103291 · NHA
BioHorizons Implant Systems, Inc.
Dental · 361d
Cleared Nov 04, 2011
MEDISIZE RED AND MEDISIZE BLUE
K110246 · CAH
Qserve America, Inc.
General Hospital · 281d
Cleared Nov 04, 2011
INTERDRY SILVER
K110715 · FRL
Milliken Healthcare Products, LLC
General Hospital · 234d
Cleared Nov 04, 2011
FXA (TM)
K110765 · LLZ
Aces GmbH
Radiology · 231d
Cleared Nov 04, 2011
PERFSCAPE V2.0
K111161 · LLZ
Olea Medical
Radiology · 193d
Cleared Nov 04, 2011
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392 · MQX
Woojeon Company
General Hospital · 170d
Cleared Nov 04, 2011
LIFTKAR PT
K111858 · ILK
Sano Transportgeraete GmbH
Physical Medicine · 127d
Cleared Nov 04, 2011
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · CAW
Respironics, Inc.
Anesthesiology · 126d
Cleared Nov 04, 2011
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K111923 · LYY
Pt. Intan Hevea Industry
General Hospital · 120d