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
30097–30120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2017
Comfort Flo Humidification System
K162242 · BTT
Teleflexmedical, Inc.
Anesthesiology · 162d
Cleared Jan 19, 2017
Titan 3 Low Speed Angle Attachments
K162397 · EGS
Dentalez, Inc.
Dental · 146d
Cleared Jan 19, 2017
Atellica CH Magnesium (Mg)
K162399 · JGJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 146d
Cleared Jan 19, 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · NBW
Ok Biotech Co., Ltd.
Chemistry · 141d
Cleared Jan 19, 2017
NC Gallant PTCA Catheter
K162434 · LOX
Medinol, Ltd.
Cardiovascular · 141d
Cleared Jan 19, 2017
TrueBeam-TrueBeam STx-Edge
K162472 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Jan 19, 2017
JAZZ FRAME SYSTEM
K162764 · NKB
Implanet, S.A.
Orthopedic · 111d
Cleared Jan 19, 2017
Ranfac Fat Aspiration Cannula
K162932 · MUU
Ranfac, Corp.
General & Plastic Surgery · 91d
Cleared Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 78d
Cleared Jan 19, 2017
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K163113 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 73d
Cleared Jan 19, 2017
LEDEX WL070+
K163605 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 29d
Cleared Jan 19, 2017
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD...
K163620 · JOW
Covidien
Cardiovascular · 28d
Cleared Jan 18, 2017
Taps for Resorbable Screws
K153587 · HBG
Synthes USA Products, LLC
Neurology · 399d
Cleared Jan 18, 2017
STIMPOD NMS460 Nerve Stimulator
K161091 · GZJ
Xavant Technology (Pty), Ltd.
Neurology · 275d
Cleared Jan 18, 2017
Bondiloxs Topical Hemostatic Granules
K161274 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 257d
Cleared Jan 18, 2017
F&P Brevida™ Nasal Pillows Mask
K161412 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 243d
Cleared Jan 18, 2017
GEO Bone Screw System
K161904 · HWC
Gramercy Extremity Orthopeidics, LLC
Orthopedic · 191d
Cleared Jan 18, 2017
Siconus SI Joint Fixation System
K162121 · OUR
Camber Spine Technologies
Orthopedic · 170d
Cleared Jan 18, 2017
EndoClot
K162197 · GCJ
Endoclot Plus Co., Ltd.
General & Plastic Surgery · 166d
Cleared Jan 18, 2017
Multi-Link X2 ECG Cable and Lead Wire System
K162432 · DSA
Carefusion 2200, Inc.
Cardiovascular · 140d
Cleared Jan 18, 2017
Breast BI 7 MR Coil Mammavention 3T
K162651 · MOS
Moras Mri Products GmbH
Radiology · 117d
Cleared Jan 18, 2017
Noddle(TM)
K162817 · ILQ
Iowa Adaptive Technologies, Inc. Dba...
Physical Medicine · 104d
Cleared Jan 18, 2017
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet,...
K162895 · MMI
Roche Diagnostics
Chemistry · 93d
Cleared Jan 18, 2017
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
K163156 · PBF
Materialise NV
Orthopedic · 69d