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
60865–60888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2006
PEAK SE, MODEL 5135
K063558 · KLE
Ultradent Products, Inc.
Dental · 17d
Cleared Dec 14, 2006
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
K063579 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 14d
Cleared Dec 14, 2006
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K063580 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Dec 13, 2006
NFIX II PEDICLE SCREW SYSTEM
K061774 · NQP
N-Spine, Inc.
Orthopedic · 173d
Cleared Dec 13, 2006
ZOLL E SERIES WITH REAL CPR HELP
K062177 · MKJ
ZOLL Medical Corporation
Cardiovascular · 135d
Cleared Dec 13, 2006
AESKULSKA BETA2-GLYCO-A
K062217 · MSV
Aesku, Inc.
Immunology · 134d
Cleared Dec 13, 2006
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
K062612 · MSS
Rayner Surgical, Inc.
Ophthalmic · 99d
Cleared Dec 13, 2006
BIS BILATERAL SENSOR
K062692 · GXY
Aspect Medical Systems, Inc.
Neurology · 93d
Cleared Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
K062708 · MST
Inova Diagnostics, Inc.
Immunology · 93d
Cleared Dec 13, 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · HSD
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Dec 13, 2006
TF ROTARY NICKEL TITANIUM FILE
K062856 · EKS
Ormco Corp.
Dental · 79d
Cleared Dec 13, 2006
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
K062922 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 76d
Cleared Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
K063343 · HLI
Bioptigen, Inc.
Ophthalmic · 37d
Cleared Dec 13, 2006
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
K063426 · OMP
Kci USA, Inc.
General & Plastic Surgery · 30d
Cleared Dec 13, 2006
ARTHREX PUSHLOCK
K063479 · HWC
Arthrex, Inc.
Orthopedic · 26d
Cleared Dec 12, 2006
CYSTOGLIDE INTRODUCER SHEATH
K052298 · KNY
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 476d
Cleared Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS...
K052465 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 460d
Cleared Dec 12, 2006
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
K061033 · KCT
Miltex, Inc.
General Hospital · 242d
Cleared Dec 12, 2006
BIOSTAR OIA SHIGATOX
K061889 · GMZ
Inverness Medical-Biostar, Inc.
Microbiology · 162d
Cleared Dec 12, 2006
TAP III ANTI-SNORING DEVICE
K062951 · LRK
Airway Management, Inc.
Dental · 74d
Cleared Dec 12, 2006
VECTORVISION HIP SR
K063028 · HAW
Brainlab AG
Neurology · 71d
Cleared Dec 12, 2006
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
K063080 · GZB
Advanced Neuromodulation Systems
Neurology · 63d
Cleared Dec 12, 2006
MEDWEB ADVANCED 3D WEB PACS
K063221 · LLZ
Nexsys Electronics, Inc.
Radiology · 49d
Cleared Dec 12, 2006
RCHIVE PACS
K063253 · LLZ
Sobha Renaissance Information...
Radiology · 46d