Search FDA 510(k) Database

7,095 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20545–20568 of 174,061
Cleared Aug 15, 2019
Suprasorb A + Ag “R”
K183208 · FRO
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 269d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared Aug 15, 2019
Biovitals Analytics Engine
K183282 · PLB
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 262d
Cleared Aug 15, 2019
Viola
K190264 · NEW
Meditime Co., Ltd.
General & Plastic Surgery · 188d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 15, 2019
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 157d
Cleared Aug 15, 2019
HeartFlow FFRct Analysis
K190925 · PJA
HeartFlow, Inc.
Cardiovascular · 128d
Cleared Aug 15, 2019
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal...
K190991 · MBH
Howmedica Osteonics Corp. (Aka...
Orthopedic · 122d
Cleared Aug 15, 2019
TULSA-PRO System
K191200 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Aug 15, 2019
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical...
K191621 · ODP
Choice Spine, LLC
Orthopedic · 58d
Cleared Aug 15, 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · FWP
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 29d
Cleared Aug 15, 2019
ACUSON P200 Diagnostic Ultrasound System
K191922 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 14, 2019
SleepImage System
K182618 · MNR
Mycardio, LLC Dba Sleepimage.
Anesthesiology · 324d
Cleared Aug 14, 2019
Servator C SALF Solution
K190063 · MSB
S.A.L.F. Spa
Gastroenterology & Urology · 211d
Cleared Aug 14, 2019
BOSS Toe Fixation System
K190261 · KWD
Arthrosurface, Inc.
Orthopedic · 187d
Cleared Aug 14, 2019
SignalMark Breast Marker
K190689 · NEU
View Point Medical, Inc.
General & Plastic Surgery · 149d
Cleared Aug 14, 2019
IS-III active System_S-narrow Type
K190849 · DZE
Neobiotech Co., Ltd.
Dental · 135d
Cleared Aug 14, 2019
Zurich Pressure Guidewire System Model 100
K190852 · DXO
Zurich Medical, Inc.
Cardiovascular · 134d
Cleared Aug 14, 2019
AutoStrut
K191241 · KTT
Orthospin
Orthopedic · 98d
Cleared Aug 14, 2019
NuVaisve® Reline® Cervical System
K191553 · NKG
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · LOL
Roche Diagnostics
Microbiology · 172d
Cleared Aug 13, 2019
PROSTEP™ TBI™ (Tailors Bunion Implant) System
K190970 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 123d
Cleared Aug 13, 2019
xPORT Lens Fragmentation System
K191024 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 117d
Cleared Aug 13, 2019
Modular Power Standing System
K191376 · IPL
Motion Concepts
Physical Medicine · 82d