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

Filters: Cleared only ×
176,076 results
63793–63816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2006
LIFENET EXCHANGE SYSTEM
K052854 · MSX
Medtronic Emergency Response Systems,...
Cardiovascular · 101d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA...
K052975 · MSX
Ge Healthcare
Cardiovascular · 88d
Cleared Jan 20, 2006
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243 · LRG
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Jan 20, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332 · DJZ
Sentech Korea Corp.
Toxicology · 50d
Cleared Jan 20, 2006
ESKA-LIBUR HIP STEM
K053557 · LPH
Eska Implants GmbH & Co.
Orthopedic · 30d
Cleared Jan 20, 2006
PF4 ENHANCED SOLID PHASE ELISA
K053559 · LCO
Genetic Testing Institute
Hematology · 30d
Cleared Jan 20, 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 17d
Cleared Jan 20, 2006
AUTOQUANT PLUS
K060020 · KPS
Adac Laboratories
Radiology · 16d
Cleared Jan 20, 2006
STELLAR 404T
K060058 · MWI
Larsen & Toubro Limited
Cardiovascular · 11d
Cleared Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
K042504 · FOZ
Myco Medical Supplies, Inc.
General Hospital · 491d
Cleared Jan 19, 2006
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION...
K051435 · NUA
Clinical Micro Sensors
Pathology · 232d
Cleared Jan 19, 2006
VASCON NEUROPATH GUIDING CATHETER
K052004 · DQY
Vascon, LLC
Cardiovascular · 178d
Cleared Jan 19, 2006
VERSATREK MYCO PZA KIT
K052323 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Jan 19, 2006
PATHWAY - ATS/CHEPS
K052357 · NTU
Medoc Ltd. Advanced Medical Systems
Neurology · 143d
Cleared Jan 19, 2006
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · DRA
St Jude Medical
Cardiovascular · 122d
Cleared Jan 19, 2006
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
K052651 · MSS
Rayner Surgical, Inc.
Ophthalmic · 115d
Cleared Jan 19, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · LYZ
Shijiazhuang Brilliant Ocean Plastic...
General Hospital · 112d
Cleared Jan 19, 2006
SPORTMESH
K052830 · FTL
Artimplant AB
General & Plastic Surgery · 106d
Cleared Jan 19, 2006
NITRILE BLUE POWDERED EXAMINATION GLOVES
K052955 · LZA
Great Glove Sdn Bhd
General Hospital · 90d
Cleared Jan 19, 2006
POWDER FREE VINYL EXAMINATION GLOVE
K052985 · LYZ
Tg Medical (China) Incorporation
General Hospital · 87d
Cleared Jan 19, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K053056 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Jan 19, 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K053107 · JXG
Codman & Shurtleff, Inc.
Neurology · 76d
Cleared Jan 19, 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
K053171 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 66d
Cleared Jan 19, 2006
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
K053292 · MQP
Scient'X USA, Inc.
Orthopedic · 55d