FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68905–68928 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2004
SKY BONE EXPANDER SYSTEM
K034037 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
K040060 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 27, 2004
AC APPLICATOR, AURORA AC
K032514 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 166d
Cleared Jan 27, 2004
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G...
K033381 · MED
Discus Dental, Inc.
General Hospital · 97d
Cleared Jan 27, 2004
PLUS PIVOT LINK UNIVERSAL SYSTEM
K033508 · MNI
Spine Vision, Inc.
Orthopedic · 82d
Cleared Jan 27, 2004
NDI PASSIVE SPHERES
K033621 · HAW
Northern Digital, Inc.
Neurology · 70d
Cleared Jan 27, 2004
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K033772 · MNI
Spine Next America
Orthopedic · 55d
Cleared Jan 27, 2004
HEEL SNUGGLER, MODEL 99047
K040044 · MPO
Respironics, Inc.
Physical Medicine · 15d
Cleared Jan 26, 2004
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
K032112 · BTR
Portex , Ltd.
Anesthesiology · 201d
Cleared Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · CEW
Nichols Institute Diagnostics
Chemistry · 104d
Cleared Jan 26, 2004
PREMIER IMPLANT CEMENT, MODEL 3001450
K033309 · EMA
Premier Dental Products Co.
Dental · 104d
Cleared Jan 26, 2004
VIANOX DELIVERY SYSTEM, MODEL II
K033779 · MRN
Pulmonox Medical, Inc.
Anesthesiology · 53d
Cleared Jan 23, 2004
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
K030598 · NLQ
Medisiss
General & Plastic Surgery · 332d
Cleared Jan 23, 2004
NEWPORT E500 WAVE VENTILATOR
K030780 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 318d
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367 · GNA
Emd Chemicals, Inc.
Microbiology · 268d
Cleared Jan 23, 2004
PERIO PROTECT TRAY
K031809 · KMT
Perio Protect, LLC
Dental · 225d
Cleared Jan 23, 2004
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
K032667 · GEX
Focus Medical, LLC
General & Plastic Surgery · 148d
Cleared Jan 23, 2004
SONOSENS
K033193 · NKI
Friendly Sensors AG
Neurology · 113d
Cleared Jan 23, 2004
CARRARA PRESS SYSTEM
K033667 · EIH
Dentsply Intl.
Dental · 63d
Cleared Jan 23, 2004
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · LJT
Smiths Medical MD, Inc.
General Hospital · 60d
Cleared Jan 23, 2004
ONE COAT SE BOND
K033760 · KLE
Coltene/Whaledent, Inc.
Dental · 52d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908 · MNI
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Jan 22, 2004
MATCH MASTER LOW FUSION PORCELAIN
K024252 · EIH
Davis Schottlander & Davis, Ltd.
Dental · 395d
Cleared Jan 22, 2004
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
K030876 · ISA
Cynosure, Inc.
Physical Medicine · 308d