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
62713–62736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2006
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
K061274 · KWQ
Medtronic Sofamor Danek
Orthopedic · 17d
Cleared May 25, 2006
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
K061295 · FTC
Theralight, Inc.
General & Plastic Surgery · 16d
Cleared May 25, 2006
MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
K061303 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 15d
Cleared May 25, 2006
MEDICAL DISPLAY, MDC1900-1LG (1LR)
K061305 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 15d
Cleared May 25, 2006
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
K061326 · LLZ
Barcoview Mis Edinburgh
Radiology · 15d
Cleared May 25, 2006
PSL PORTABLE SLIT LAMP
K061330 · HJO
Reichert, Inc.
Ophthalmic · 13d
Cleared May 24, 2006
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
K050367 · KFF
Hyphen Biomed
Hematology · 464d
Cleared May 24, 2006
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
K051442 · GEX
Cynosure, Inc.
General & Plastic Surgery · 356d
Cleared May 24, 2006
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 252d
Cleared May 24, 2006
CONTACT LENS OPHTHALMODYNAMOMETER
K052674 · NYK
Meditron, GmbH
Ophthalmic · 239d
Cleared May 24, 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K053539 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 155d
Cleared May 24, 2006
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
K060381 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 99d
Cleared May 24, 2006
SPACER-S TEMPORARY SHOULDER SPACER
K060535 · HSD
Tecres S.P.A.
Orthopedic · 85d
Cleared May 24, 2006
BC100 BODY COMPOSITION ANALYSIS SYSTEM
K060552 · MNW
Athletic Iq, Inc.
Gastroenterology & Urology · 83d
Cleared May 24, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K060805 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 61d
Cleared May 24, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K060909 · LYZ
Jiangsu Everyguard Plastic Products...
General Hospital · 51d
Cleared May 24, 2006
MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL...
K060977 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 44d
Cleared May 24, 2006
BIO 1-KIT BIOSORB FILLED CARTRIDGE
K061022 · MQV
Science For Biomaterials
Orthopedic · 41d
Cleared May 24, 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
K061074 · LZA
Bright Element Sdn Bhd
General Hospital · 37d
Cleared May 24, 2006
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
K061098 · HRS
Ebi, L.P.
Orthopedic · 35d
Cleared May 24, 2006
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
K061132 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 30d
Cleared May 23, 2006
REPROCESSED ENDOSCOPIC TROCAR
K052299 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 272d
Cleared May 23, 2006
DENALI DEFORMITY SYSTEM
K052404 · KWP
K2m, LLC
Orthopedic · 264d
Cleared May 23, 2006
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822 · HLI
Keeler Instruments, Inc.
Ophthalmic · 57d