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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49753–49776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2010
HYBRID TROCAR SYSTEM
K101937 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 30d
Cleared Aug 11, 2010
COMBAT READY CLAMP
K102025 · DXC
Combat Medical Systems, LLC
Cardiovascular · 23d
Cleared Aug 11, 2010
VITABLOCS
K102128 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 13d
Cleared Aug 10, 2010
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771 · MNH
Pioneer Surgical Technology
Orthopedic · 245d
Cleared Aug 10, 2010
ARP POV SPORT
K093999 · NGX
Arp Manufacturing, Inc.
Physical Medicine · 225d
Cleared Aug 10, 2010
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
K100693 · FRO
Medtrade Products Limited
General & Plastic Surgery · 152d
Cleared Aug 10, 2010
ATLAS SPINE PIVOTING SYSTEM
K100743 · MAX
Atlas Spine, Inc.
Orthopedic · 147d
Cleared Aug 10, 2010
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 124d
Cleared Aug 10, 2010
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · GXI
Baylis Medical Co., Inc.
Neurology · 85d
Cleared Aug 10, 2010
SYNGO. PLAZA VA20A
K101666 · LLZ
Siemens AG Medical Solutions
Radiology · 57d
Cleared Aug 10, 2010
LIFELINES PHOTIC STIMULATOR
K101691 · GWE
Lifelines , Ltd.
Neurology · 55d
Cleared Aug 10, 2010
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
K101751 · IYE
Varian Medical Systems, Oncology Systems
Radiology · 49d
Cleared Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K101960 · HEP
Edan Instruments, Inc.
Radiology · 29d
Cleared Aug 09, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
K091090 · MQB
E-Woo Technology
Radiology · 480d
Cleared Aug 09, 2010
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY
K100887 · KCT
Tag Medical Products
General Hospital · 132d
Cleared Aug 09, 2010
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
K100918 · FRO
Puricore, Inc.
General & Plastic Surgery · 129d
Cleared Aug 09, 2010
WELLMIEN SURGICAL MASK
K101000 · FXX
Wellmien (Suzhou) Import & Export...
General Hospital · 119d
Cleared Aug 09, 2010
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
K101122 · LPL
Benz Research and Development Corp.
Ophthalmic · 110d
Cleared Aug 09, 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K101134 · MSS
Medicel AG
Ophthalmic · 109d
Cleared Aug 09, 2010
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC...
K101452 · KPT
Capintec, Inc.
Radiology · 76d
Cleared Aug 09, 2010
ALLURA XPER OR TABLE SERIES
K102005 · OWB
Philips Medical Systems North...
Radiology · 25d
Cleared Aug 07, 2010
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · KRH
Medtronic, Inc.
Cardiovascular · 99d
Cleared Aug 06, 2010
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
K092029 · BYE
Draeger Medical AG & Co. KG
Anesthesiology · 396d
Cleared Aug 06, 2010
ABL90 FLEX SERIES
K092686 · CEM
Radiometer Medical Aps
Chemistry · 338d