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
26545–26568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2018
IRENE Thoracolumbar Fixation System
K172267 · NKB
Tianjin Zhengtian Medical Instrument...
Orthopedic · 222d
Cleared Mar 06, 2018
Digitimer DS7AP Constant Current Stimulator
K172381 · IPF
Digitimer , Ltd.
Physical Medicine · 211d
Cleared Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · OWQ
Innovative Health, LLC
Cardiovascular · 146d
Cleared Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
K173356 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 132d
Cleared Mar 06, 2018
OrthoSteady G Bone Cement
K173494 · LOD
G21, S.R.L.
Orthopedic · 113d
Cleared Mar 05, 2018
HammerTube System
K171715 · HTY
Paragon 28
Orthopedic · 269d
Cleared Mar 05, 2018
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well...
K172062 · SCL
Medscience Science Research Group, Inc.
General Hospital · 241d
Cleared Mar 05, 2018
Cytology Brush
K172663 · FDX
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Mar 05, 2018
DePuy Synthes Femoral Neck System
K172872 · KTT
DePuy Synthes
Orthopedic · 165d
Cleared Mar 05, 2018
Valeo® C+CSC with Lumen Interbody Fusion Device
K173453 · ODP
Amedica Corp.
Orthopedic · 119d
Cleared Mar 05, 2018
EMPOWR Universal Tibial Baseplate
K173723 · JWH
Encore Medical, L.P.
Orthopedic · 90d
Cleared Mar 05, 2018
Reprocessed ArthoCare Ablation Wand
K173741 · NUJ
Renovo, Inc.
General & Plastic Surgery · 88d
Cleared Mar 05, 2018
MiniMed Mio Advance infusion set
K173879 · FPA
Unomedical A/S
General Hospital · 74d
Cleared Mar 05, 2018
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with...
K173942 · LZC
Central Medicare Sdn Bhd
General Hospital · 69d
Cleared Mar 05, 2018
LEGION Knee System
K180334 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Mar 02, 2018
Omega VL
K162366 · NEW
Ov World Co., Ltd.
General & Plastic Surgery · 556d
Cleared Mar 02, 2018
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
K170304 · FLE
Astell Scientific Limited
General Hospital · 395d
Cleared Mar 02, 2018
CO Check Pro, CO Screen
K171129 · CCJ
MD Diagnostics Limited
Anesthesiology · 319d
Cleared Mar 02, 2018
Infrared Thermometer
K171214 · FLL
Shenzhen Brav Electronic Technologies...
General Hospital · 311d
Cleared Mar 02, 2018
cobas m 511 integrated hematology analyzer
K171655 · GKZ
Roche Diagnostics Hematology, Inc.
Hematology · 270d
Cleared Mar 02, 2018
Flowtron DVT5 Small Calf Garment
K172103 · JOW
Getinge (Suzhou) Co., Ltd.
Cardiovascular · 233d
Cleared Mar 02, 2018
uCT Computed Tomography X-ray System
K172135 · JAK
Shanghai United Imaging Healthcare...
Radiology · 231d
Cleared Mar 02, 2018
SoftVue
K172256 · IYO
Delphinus Medical Technologies
Radiology · 219d
Cleared Mar 02, 2018
Type I, Type II, Type III, Type IV
K172331 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 212d