Search FDA 510(k) Database

7,165 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
23113–23136 of 174,061
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 26, 2018
InMode RF System
K182325 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 30d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Sep 25, 2018
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1...
K173127 · LCP
Skyla Corporation H.S.P.B
Chemistry · 361d
Cleared Sep 25, 2018
PeDIA
K181424 · BTC
Pedia, LLC
Anesthesiology · 117d
Cleared Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag...
K181692 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2018
Synapse 3D Optional Tools
K181773 · LLZ
Fujifilm Corporation
Radiology · 84d
Cleared Sep 25, 2018
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 82d
Cleared Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904 · LJS
Piper Access, LLC
General Hospital · 71d
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Alphatec Spine, Inc.
Orthopedic · 62d
Cleared Sep 25, 2018
IBM iConnect Access
K182290 · LLZ
Merge Healthcare Incorporated
Radiology · 33d
Cleared Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 28d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 24, 2018
iNtuition-T1 Mapping and T2/T2* Mapping
K180916 · LLZ
Terarecon,Inc.
Radiology · 168d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Sep 24, 2018
Comprehensive Reverse Shoulder System
K181611 · PHX
Biomet Manufacturing Corp
Orthopedic · 97d
Cleared Sep 24, 2018
AMADEO M-DR mini, AMADEO M-AX mini
K182317 · IZL
Oehm Und Rehbein GmbH
Radiology · 28d
Cleared Sep 21, 2018
SOLOASSIST II
K171947 · NAY
Aktormed GmbH
General & Plastic Surgery · 449d
Cleared Sep 21, 2018
OpenSight
K172418 · LLZ
Novarad Corporation
Radiology · 407d
Cleared Sep 21, 2018
DePuy Corail AMT Hip Prosthesis
K173960 · LZO
Depuy France S.A.S.
Orthopedic · 267d
Cleared Sep 21, 2018
Malecot Nephrostomy Catheter/Stent Set
K180029 · FAD
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 246d
Cleared Sep 21, 2018
Cellulize
K180338 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 226d
Cleared Sep 21, 2018
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K180489 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 210d