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
46249–46272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2011
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K112646 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Oct 11, 2011
HEALTH-E-CONNECT SYSTEM
K102063 · NBW
Alr Technologies
Chemistry · 445d
Cleared Oct 11, 2011
CONCORDE BULLET SPINAL SYSTEM
K110694 · MAX
Johnson & Johnson
Orthopedic · 211d
Cleared Oct 11, 2011
RELIEVA SPIN SINUS DILATION SYSTEM
K111875 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 102d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · HWC
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
K112017 · GWM
Raumedic AG
Neurology · 89d
Cleared Oct 11, 2011
APEX KIRSCHNER WIRES AND STEINMANN PINS
K112254 · HTY
Apex Tools & Orthopedics Co.
Orthopedic · 67d
Cleared Oct 11, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · PHX
Tornier, Inc.
Orthopedic · 33d
Cleared Oct 11, 2011
ONSET ACCESS CATHETER SYSTEM
K112629 · DQY
Onset Medical Corporation
Cardiovascular · 32d
Cleared Oct 11, 2011
SURESIGNS VS2+ -SURESIGNS VSI
K112652 · DXN
Philips Medical Systems
Cardiovascular · 29d
Cleared Oct 07, 2011
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
K102316 · CGA
Broadmaster Biotech Corporation
Chemistry · 417d
Cleared Oct 07, 2011
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION...
K102772 · OAV
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 378d
Cleared Oct 07, 2011
BABI PLUS INFANT NASAL CANNULA SYSTEM
K110471 · BZD
A Plus Medical
Anesthesiology · 231d
Cleared Oct 07, 2011
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
K110687 · KAM
Acclarent, Inc.
General & Plastic Surgery · 210d
Cleared Oct 07, 2011
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL...
K110780 · CIG
Elitechgroup
Chemistry · 200d
Cleared Oct 07, 2011
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
K110836 · KWA
Zimmer GmbH
Orthopedic · 196d
Cleared Oct 07, 2011
GLOBALCARDIO
K111320 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 150d
Cleared Oct 07, 2011
HUIBAO BODY FAT SCALE
K111404 · MNW
Zhongshan Huibao Weighing Apparatus...
Gastroenterology & Urology · 141d
Cleared Oct 07, 2011
OSTEOMED HAND FUSION SYSTEM
K111419 · HRS
Osteomed LP
Orthopedic · 140d
Cleared Oct 07, 2011
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
K111532 · EGS
Anthogyr Sas
Dental · 126d
Cleared Oct 07, 2011
PRECISION FLOW(R) - HELIOX
K111640 · BTT
Vapotherm, Inc.
Anesthesiology · 116d
Cleared Oct 07, 2011
VENUS SWAN SYSTEM
K111784 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 108d
Cleared Oct 07, 2011
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
K111859 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 99d
Cleared Oct 07, 2011
MECTACER BIOLOX(R) DELTA FEMORAL HEADS
K112115 · LZO
Medacta International
Orthopedic · 74d