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
53425–53448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 29, 2009
THE CROSSER 14 OTW CATHETER, MODEL CRU014
K091254 · DQY
Flowcardia, Inc.
Cardiovascular · 30d
Cleared May 29, 2009
RESPIRONICS PERFORMAX TOTAL FACE MASK
K091271 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 29d
Cleared May 29, 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · DYB
Terumo Medical Corp.
Cardiovascular · 24d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · MQB
Canon, Inc.
Radiology · 15d
Cleared May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · JBQ
Siemens Healthcare Diagnostics
Hematology · 339d
Cleared May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY,...
K083117 · LKO
Phadia US, Inc.
Immunology · 218d
Cleared May 28, 2009
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K090071 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 136d