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
51841–51864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2009
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
K091725 · MNH
U&I Corp.
Orthopedic · 151d
Cleared Nov 09, 2009
SPINEOLOGY FACET SCREW
K092464 · MRW
Spineology, Inc.
Orthopedic · 90d
Cleared Nov 09, 2009
GREENLIGHT XPS LASER SYSTEM
K092735 · GEX
American Medical Systems, Inc.
General & Plastic Surgery · 66d
Cleared Nov 09, 2009
DENSICHECK PLUS
K093224 · LON
bioMerieux, Inc.
Microbiology · 26d
Cleared Nov 06, 2009
SHIMADZU COLLIMATOR R-30H
K090578 · IZW
Shimadzu Corp.
Radiology · 248d
Cleared Nov 06, 2009
CLAMPFIX
K090605 · NKB
Synthes (Usa)
Orthopedic · 245d
Cleared Nov 06, 2009
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER
K091241 · DQA
Masimo Corporation
Anesthesiology · 193d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Nov 06, 2009
VIGILANT EEG MONITOR, VIGILANT 2.0
K091963 · OLT
Infinite Biomedical Technologies, LLC
Neurology · 128d
Cleared Nov 06, 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260,...
K092009 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 123d
Cleared Nov 06, 2009
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND...
K092400 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 92d
Cleared Nov 06, 2009
CASPIAN SPINAL SYSTEM
K092640 · MNI
K2m, Inc.
Orthopedic · 71d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Nov 06, 2009
CADSTREAM VERSION 5
K092954 · LLZ
Confirma, Inc.
Radiology · 42d
Cleared Nov 06, 2009
ENVOY GUIDING CATHETERS
K093184 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · MCW
Ev3, Inc.
Cardiovascular · 16d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · DWM
Pfm Medical, Inc.
Anesthesiology · 15d
Cleared Nov 05, 2009
PECTUS STRUT
K082399 · HRS
Koros USA, Inc.
Orthopedic · 442d
Cleared Nov 05, 2009
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD
K090804 · BZD
Innomed Technologies, Inc./Respcare,...
Anesthesiology · 225d
Cleared Nov 05, 2009
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
K091309 · HSB
Dgimed Ortho, Inc.
Orthopedic · 185d
Cleared Nov 05, 2009
GDS-DCS
K091367 · DYB
Guided Delivery Systems
Cardiovascular · 181d
Cleared Nov 05, 2009
LH-75 PHOTOTHERAPY SYSTEM
K091568 · FTC
Lerner Medical Devices, Inc.
General & Plastic Surgery · 156d
Cleared Nov 05, 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · HWC
Arthrocare Corp.
Orthopedic · 113d
Cleared Nov 05, 2009
MODIFICATION TO MODIFIED HD GUIDE CATHETER
K092298 · DQY
Concentric Medical, Inc.
Cardiovascular · 99d