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
63241–63264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2006
INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
K060074 · FPA
Baxter Healthcare Corp
General Hospital · 78d
Cleared Mar 29, 2006
CLEANSE S+ ULTRASONIC SCALER
K060171 · ELC
Dmetec.Co., Ltd.
Dental · 65d
Cleared Mar 29, 2006
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
K060197 · DQD
Zargis Medical Corp.
Cardiovascular · 62d
Cleared Mar 29, 2006
PILL PHONE
K060298 · NXQ
Vocel
General Hospital · 51d
Cleared Mar 29, 2006
FRAXEL II SR LASER SYSTEM AND ACCESSORIES
K060310 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 50d
Cleared Mar 29, 2006
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K060332 · NUN
Isotis NV
Dental · 48d
Cleared Mar 29, 2006
O-ARM IMAGING SYSTEM
K060344 · OXO
Breakaway Imaging, LLC
Radiology · 47d
Cleared Mar 29, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.
K060493 · LON
Becton, Dickinson & CO
Microbiology · 33d
Cleared Mar 29, 2006
VOXAR 3D ENTERPRISE, MODEL 6.1
K060505 · LLZ
Barcoview Mis Edinburgh
Radiology · 30d
Cleared Mar 29, 2006
ACCESS BREAST COIL 4/SMS
K060547 · MOS
Confirma, Inc.
Radiology · 28d
Cleared Mar 29, 2006
PEDIATRIC URETERAL STENT
K060673 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 15d
Cleared Mar 28, 2006
ACULIFE, MODEL SMW-01
K051197 · BWK
Inno-Health Technology, Inc.
Neurology · 322d
Cleared Mar 28, 2006
POREX ELECTROSURGERY NEEDLE
K052297 · GEI
Porex Surgical, Inc.
General & Plastic Surgery · 217d
Cleared Mar 28, 2006
IQMARK EZ STRESS
K052898 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 165d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072 · DEM
Dade Behring, Inc.
Immunology · 147d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · DEB
Dade Behring, Inc.
Immunology · 147d
Cleared Mar 28, 2006
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
K053079 · CGA
Hypoguard USA, Inc.
Chemistry · 146d
Cleared Mar 28, 2006
SYVEKEXCEL
K053300 · DXC
Marine Polymer Technologies, Inc.
Cardiovascular · 123d
Cleared Mar 28, 2006
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
K060403 · LXT
Meridian Medical
Orthopedic · 41d
Cleared Mar 28, 2006
COULTER 5C CELL CONTROL
K060464 · JPK
Beckman Coulter, Inc.
Hematology · 34d
Cleared Mar 28, 2006
OPTIBOND ALL-IN-ONE
K060469 · KLE
Sybron Dental Specialties, Inc.
Dental · 33d
Cleared Mar 28, 2006
VITAMESH MACROPOROUS PP SURGICAL MESH
K060520 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 29d
Cleared Mar 28, 2006
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
K060523 · OMC
Cyberkinetics, Inc.
Neurology · 29d
Cleared Mar 28, 2006
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · GAR
Aesculap, Inc.
General & Plastic Surgery · 28d