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
46105–46128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2011
FIXATE TISSUE BAND
K112849 · GZB
Anulex Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Oct 27, 2011
FETAL DOPPLER
K112911 · KNG
Beijing Choice Electronic Technololgy...
Radiology · 24d
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART...
K112917 · DQY
Medtronic, Inc.
Cardiovascular · 24d
Cleared Oct 26, 2011
EXPEDIUM SPINE SYSTEM
K110551 · NKB
Johnson & Johnson
Orthopedic · 240d
Cleared Oct 26, 2011
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
K111512 · MAX
Thompson Mis, Inc.
Orthopedic · 147d
Cleared Oct 26, 2011
IPC POWEREASE SYSTEM
K111520 · HBE
Medtronic Xomed, Inc.
Neurology · 146d
Cleared Oct 26, 2011
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY...
K111621 · DQA
Masimo Corporation
Anesthesiology · 138d
Cleared Oct 26, 2011
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY...
K111822 · KFF
Diagnostica Stago, Inc.
Hematology · 120d
Cleared Oct 26, 2011
CLEARSPLINT ES
K111828 · MQC
Astron Dental Corporation
Dental · 120d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · LON
bioMerieux, Inc.
Microbiology · 105d
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174 · HRS
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 26, 2011
US-101L, US-103S
K112520 · IMI
Ito Co., Ltd.
Physical Medicine · 56d
Cleared Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689 · HRS
Synthes, Inc.
Orthopedic · 41d
Cleared Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · NHX
Bio-Rad Laboratories
Immunology · 29d
Cleared Oct 25, 2011
I-NEB AAD SYSTEM WITH TIM
K102454 · CAF
Respironics Respiratory Drug Delivery...
Anesthesiology · 424d
Cleared Oct 25, 2011
AFFIRM (TM) VCF SYSTEM
K110998 · NDN
Algea Therapies
Orthopedic · 197d
Cleared Oct 25, 2011
SKAFFOLD CIS
K111538 · MTJ
Skeletal Kinetics, LLC
General & Plastic Surgery · 145d
Cleared Oct 25, 2011
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM)...
K111825 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 119d
Cleared Oct 25, 2011
VUSION(R) OS
K111965 · MAX
Ortho Development
Orthopedic · 106d
Cleared Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Oct 25, 2011
HEALIX KNOTLESS(TM) ANCHOR
K112249 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared Oct 25, 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · FGE
Boston Scientific
Gastroenterology & Urology · 39d
Cleared Oct 25, 2011
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
K112786 · FTM
Synovis Orthopedic and Woundcare, Inc.
General & Plastic Surgery · 29d
Cleared Oct 25, 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 27d