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
53161–53184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 01, 2009
PATHWAY AVID
K090566 · MAX
Custom Spine, Inc.
Orthopedic · 90d
Cleared Jun 01, 2009
COMPEX REHAB
K090632 · IPF
Chattanooga Group
Physical Medicine · 84d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · DKB
Siemens Healthcare Diagnostics
Toxicology · 61d
Cleared Jun 01, 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · HWC
Medacta International S.A.
Orthopedic · 48d
Cleared Jun 01, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
K091151 · LZA
Gx Corporation Sdn Bhd
General Hospital · 42d
Cleared Jun 01, 2009
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
K091322 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 27d
Cleared May 29, 2009
ISOFLOW INFUSION CATHETER
K081147 · KRA
Vascular Designs, Inc.
Cardiovascular · 402d
Cleared May 29, 2009
EXTT-101
K082436 · HIR
Apimeds, Inc.
Gastroenterology & Urology · 277d
Cleared May 29, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER...
K082957 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 238d
Cleared May 29, 2009
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
K083598 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 175d
Cleared May 29, 2009
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · QJQ
Johari Digital Healthcare , Ltd.
Neurology · 142d
Cleared May 29, 2009
QMS LIDOCAINE
K090282 · KLR
Thermo Fisher Scientific, Inc.
Toxicology · 113d
Cleared May 29, 2009
SRI LEVEL II SURGICAL GOWN
K090383 · FYA
Sri Surgical
General Hospital · 101d
Cleared May 29, 2009
MODEL 350G GAS CONSERVER
K090421 · NFB
Inspired Technologies, Inc.
Anesthesiology · 100d
Cleared May 29, 2009
HEMORPEX SYSTEM
K090432 · FER
Angiologica B. M. Srl
Gastroenterology & Urology · 99d
Cleared May 29, 2009
TANTHERA-T35
K090831 · LEJ
Tanthera, Inc.
General & Plastic Surgery · 64d