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
38161–38184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2014
GENERAL AND PLASTIC SURGERY
K140835 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 48d
Cleared May 20, 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925 · MBI
Acumed, LLC
Orthopedic · 39d
Cleared May 20, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · MNH
Spineart
Orthopedic · 36d
Cleared May 20, 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · HSB
Ellipse Technologies, Inc.
Orthopedic · 29d
Cleared May 19, 2014
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · MYA
Leica Biosystems Newcastle, Ltd.
Pathology · 635d
Cleared May 19, 2014
MAXIO
K132108 · JAK
Perfint Healthcare Pvt, Ltd.
Radiology · 315d
Cleared May 19, 2014
THUNDERBEAT
K132703 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 263d
Cleared May 19, 2014
DMS 300-2W HOLTER ECG RECORDER
K133014 · MWJ
Diagnostic Monitoring Software
Cardiovascular · 236d
Cleared May 19, 2014
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
K133793 · OMB
Persyst Development Corporation
Neurology · 157d
Cleared May 19, 2014
VIEWFLEX XTRA ICE CATHETER
K133853 · OBJ
Irvine Biomedical, Inc., A St. Jude...
Cardiovascular · 151d
Cleared May 19, 2014
NXSTAGE SYSTEM ONE
K140526 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 76d
Cleared May 19, 2014
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450,...
K141015 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 28d
Cleared May 19, 2014
CS2 MULTI-HOLE ACETABULAR SHELL
K141043 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared May 16, 2014
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
K131096 · NRB
Arobella Medical, LLC
General & Plastic Surgery · 393d
Cleared May 16, 2014
VITAL SIGNS MONITOR
K132037 · MWI
Mindray North America
Cardiovascular · 319d
Cleared May 16, 2014
NUVASIVE NVM5 SYSTEM
K132694 · PDQ
Nu Vasive, Incorporated
Neurology · 260d
Cleared May 16, 2014
BIOPSY PIPETTES
K133257 · MQH
Research Instruments , Ltd.
Obstetrics & Gynecology · 205d
Cleared May 16, 2014
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
K133519 · JJE
Carolina Liquid Chemistries Corp.
Chemistry · 182d
Cleared May 16, 2014
TEMPUS PRO EXTENDED FEATURES
K133988 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 141d
Cleared May 16, 2014
RESCAN
K140054 · BZD
Resmed, Ltd.
Anesthesiology · 127d
Cleared May 16, 2014
AXERA RX ACCESS SYSTEM
K140287 · DYB
Arstasis, Inc.
Cardiovascular · 100d
Cleared May 16, 2014
LUMENA FH HAIR REMOVAL SYSTEM
K140631 · ONF
Shaser, Inc.
General & Plastic Surgery · 65d
Cleared May 16, 2014
VSCAN WITH DUAL PROBE
K140693 · IYN
Ge Medical Sysyems Ultrasound &...
Radiology · 58d
Cleared May 16, 2014
KLASSIC KNEE TIBIAL STEM EXTENSION
K140942 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 32d