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
60097–60120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2007
PLASMACON N, PLASMACON L-1, PLASMACON L-2
K062306 · GGC
R2 Diagnostics, Inc.
Hematology · 220d
Cleared Mar 16, 2007
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · HHT
Diamics, Inc.
Obstetrics & Gynecology · 207d
Cleared Mar 16, 2007
OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
K062521 · JIT
Thermo-Electron Corp.
Chemistry · 200d
Cleared Mar 16, 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976 · DSI
Ge Medical Systems Information...
Cardiovascular · 168d
Cleared Mar 16, 2007
FUJINON MODEL EG-530N TRANS NASAL INSERTION
K063316 · FDS
Fujinon, Inc.
Gastroenterology & Urology · 134d
Cleared Mar 16, 2007
DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
K063384 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 128d
Cleared Mar 16, 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
K063432 · HSX
Conformis, Inc.
Orthopedic · 123d
Cleared Mar 16, 2007
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K070214 · MBH
Zimmer, Inc.
Orthopedic · 52d
Cleared Mar 16, 2007
VARI-LASE BRIGHT TIP FIBER
K070216 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 52d
Cleared Mar 16, 2007
LERADO, POWER WHEELCHAIR, PB
K070433 · ITI
Lerado China Limited
Physical Medicine · 30d
Cleared Mar 16, 2007
BIOMARC GOLD TISSUE MARKER
K070436 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Mar 16, 2007
BD HYPOINT NEEDLE
K070440 · FMI
Becton, Dickinson & CO
General Hospital · 29d
Cleared Mar 16, 2007
POWERLED SURGICAL LIGHT SYSTEM
K070442 · FSY
Maquet S.A.
General & Plastic Surgery · 29d
Cleared Mar 16, 2007
ONDEMAND3D
K070464 · LLZ
Cybermed, Inc.
Radiology · 28d
Cleared Mar 16, 2007
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · DXO
Volcano Corporation
Cardiovascular · 24d
Cleared Mar 16, 2007
VIDAR VISION 2000
K070563 · MQB
Vidar Systems Corp.
Radiology · 17d
Cleared Mar 15, 2007
UNITIP HIGH RESOLUTION CATHETER
K062222 · FFX
Unisensor AG
Gastroenterology & Urology · 225d
Cleared Mar 15, 2007
PROCHEM EXT CHEMICAL INTEGRATOR
K062651 · JOJ
Raven Biological Laboratories, Inc.
General Hospital · 189d
Cleared Mar 15, 2007
UNITY ALPHA SYSTEM
K062820 · HWC
Bonutti Research, Inc.
Orthopedic · 176d
Cleared Mar 15, 2007
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
K063210 · DQX
Medtronic Inc. Cardiac Rhythm Management
Cardiovascular · 143d
Cleared Mar 15, 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · DQK
Spacelabs Medical, Inc.
Cardiovascular · 118d
Cleared Mar 15, 2007
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
K063581 · LYY
Pt Mahakarya Inti Buana
General Hospital · 105d
Cleared Mar 15, 2007
FREQUENCER, MODEL 1001
K063645 · BYI
Dymedso, Inc.
Anesthesiology · 98d
Cleared Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
K063844 · NQG
Sterilmed, Inc.
Cardiovascular · 79d