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
53137–53160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
K090771 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
K090772 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
C-QUR V -PATCH MESH
K090909 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 64d
Cleared Jun 04, 2009
FLOW CONTROLLER
K090938 · LZU
Odyssey Medical, Inc.
Ophthalmic · 62d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 59d
Cleared Jun 04, 2009
SPEEDCEM
K091019 · EMA
Ivoclar Vivadent, Inc.
Dental · 56d
Cleared Jun 04, 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL,...
K091253 · KWQ
K2m, Inc.
Orthopedic · 36d
Cleared Jun 04, 2009
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
K091323 · GEX
Intermedic Arfran, SA
General & Plastic Surgery · 30d
Cleared Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
K091368 · LLZ
Hologic, Inc.
Radiology · 27d
Cleared Jun 03, 2009
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL...
K083336 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 203d
Cleared Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · DPS
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Jun 03, 2009
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 03, 2009
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY...
K090737 · JKA
Bio-Rad Laboratories, Inc.
Chemistry · 75d
Cleared Jun 02, 2009
MASTERGRAFT STRIP
K082166 · MQV
Medtronic Sofamor Danek
Orthopedic · 306d
Cleared Jun 02, 2009
I-MAX TOUCH
K083057 · MUH
Owandy
Radiology · 231d
Cleared Jun 02, 2009
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
K083917 · OAS
Suni Medical Imaging, Inc.
Radiology · 154d
Cleared Jun 02, 2009
EASY ON-PC SPIROMETER
K090034 · BZG
Ndd Medizitechnik AG
Anesthesiology · 147d
Cleared Jun 02, 2009
NEXLINK OCT SYSTEM, MODEL 7000 SERIES
K090060 · KWP
Abbott Spine, Inc.
Orthopedic · 144d
Cleared Jun 02, 2009
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
K090206 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 125d
Cleared Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · KFF
Instrumentation Laboratory CO
Hematology · 125d
Cleared CT Jun 02, 2009
BACKSTOP AND BACKSTOP INJECTOR
K090430 · ONJ
Pluromed, Inc.
Gastroenterology & Urology · 103d
Cleared Jun 02, 2009
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · FZE
Nobel Biocare AB
General & Plastic Surgery · 85d
Cleared Jun 02, 2009
MEGAPULSE LASER SYSTEM AND FIBERS
K090776 · GEX
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 71d