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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53401–53424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · MKZ
Becton, Dickinson & CO
Microbiology · 68d
Cleared Jun 02, 2009
PENTA LEAD KITS, MODELS: 3227-3234
K090907 · GZB
Advanced Neuromodulation Systems
Neurology · 62d
Cleared Jun 02, 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 61d
Cleared Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
K091346 · JXG
Codman & Shurtleff, Inc.
Neurology · 26d
Cleared Jun 01, 2009
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K083899 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 154d
Cleared Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
K090412 · LZA
Gx Corporation Sdn Bhd
General Hospital · 103d
Cleared Jun 01, 2009
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
K090415 · KWQ
Eminent Spine
Orthopedic · 103d
Cleared Jun 01, 2009
LOI SYSTEM
K090525 · ONG
Palomar Medical Products, Inc.
General & Plastic Surgery · 95d