FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
29761–29784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2017
Cascade IOMAX Intraoperative Monitor
K162199 · GWF
Cadwell Industries, Inc.
Neurology · 209d
Cleared Mar 02, 2017
Vesair Cystoscopic Sheath
K162356 · KNY
Solace Therapeutics
Gastroenterology & Urology · 191d
Cleared Mar 02, 2017
Intellijoint HIP Generation 2A System
K162364 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 191d
Cleared Mar 02, 2017
TIPCAM 1S 3D System
K162410 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 185d
Cleared Mar 02, 2017
MR Conditional CGA 870
K162811 · CAN
Essex Industries, Inc.
Anesthesiology · 147d
Cleared Mar 02, 2017
KneeAlign 2 System
K163379 · OLO
Orthalign, Inc.
Orthopedic · 91d
Cleared Mar 02, 2017
EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard...
K163497 · KWZ
Encore Medical, L.P.
Orthopedic · 79d
Cleared Mar 02, 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · GDW
Covidien
General & Plastic Surgery · 27d
Cleared Mar 02, 2017
RayStation 6
K170355 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 24d
Cleared Mar 02, 2017
n!ce Glass Ceramic Blocks for Amann Girrbach
K170420 · EIH
Institut Straumann AG
Dental · 17d
Cleared Mar 01, 2017
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment,...
K162026 · JWH
Microport Orthopedics, Inc.
Orthopedic · 222d
Cleared Mar 01, 2017
Cadwell Sierra Summit, Cadwell Sierra Ascent
K162383 · IKN
Cadwell Industries, Inc.
Neurology · 188d
Cleared Mar 01, 2017
syngo. CT Neuro Perfusion
K163284 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Mar 01, 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · MQB
Canon, Inc.
Radiology · 27d
Cleared Feb 28, 2017
On1 Concept
K161655 · NHA
Nobel Biocare AB
Dental · 257d
Cleared Feb 28, 2017
Surface Applicator Set
K162018 · JAQ
Varian Medical Systems, Inc.
Radiology · 229d
Cleared Feb 28, 2017
RTC 26-C Inline Aerosol Adapter
K162753 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 151d
Cleared Feb 28, 2017
Smart Laser Indirect Ophthalmoscope (LIO)
K162837 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 140d
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008 · DTA
Medtronic, Inc.
Cardiovascular · 123d
Cleared Feb 28, 2017
EPIC Extremity Snap-Off Screw
K163038 · HWC
Epic Extremity, LLC
Orthopedic · 120d
Cleared Feb 28, 2017
Biograph mMR with syngo MR E11P system software
K163234 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 103d
Cleared CT Feb 28, 2017
Virtual Occupational Therapy Application (VOTA)
K163245 · LXJ
Barron Associates, Inc.
Physical Medicine · 102d
Cleared Feb 28, 2017
Apex Dental Sensors
K163282 · MUH
Masterlink, LLC
Radiology · 99d
Cleared Feb 28, 2017
Biomet Fusion System
K163543 · OVD
Zimmer Biomet Spine, Inc.
Orthopedic · 74d