Search FDA 510(k) Database

7,111 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20809–20832 of 174,061
Cleared Jul 15, 2019
Lyra
K191372 · EWO
Interacoustics A/S
Ear, Nose, Throat · 54d
Cleared Jul 15, 2019
Optilite IgM Kit
K191635 · CFN
The Binding Site Group , Ltd.
Immunology · 26d
Cleared Jul 14, 2019
DROWZLE
K173974 · MNR
Resonea, Inc.
Anesthesiology · 562d
Cleared Jul 14, 2019
Modus Nav
K183325 · HAW
Synaptive Medical, Inc.
Neurology · 226d
Cleared Jul 12, 2019
Osstem Abutment System
K182091 · NHA
Osstem Implant Co., Ltd.
Dental · 343d
Cleared Jul 12, 2019
Novidia Bulk Fill Flow Composite
K182714 · EBF
Nobio , Ltd.
Dental · 288d
Cleared Jul 12, 2019
PerioLase Nd:YAG Pulsed Dental Laser System
K182930 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 263d
Cleared Jul 12, 2019
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
K183473 · NGT
Amsino International, Inc.
General Hospital · 210d
Cleared Jul 12, 2019
VERITON CT whole body SPECT/CT system
K190457 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 137d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · EOB
Ambu A/S
Ear, Nose, Throat · 88d
Cleared Jul 12, 2019
Radial Medical Compression System
K190976 · JOW
Radial Medical, Inc.
Cardiovascular · 88d
Cleared Jul 12, 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K190999 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 87d
Cleared Jul 12, 2019
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic...
K191050 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 12, 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · HRX
Stryker Corp.
General & Plastic Surgery · 63d
Cleared Jul 12, 2019
Wearable Device, Wearable Package
K191272 · MSX
Current Health , Ltd.
Cardiovascular · 60d
Cleared Jul 12, 2019
Remington Medical, Inc. Automatic Cutting Needle (NAC)
K191315 · KNW
Remington Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 12, 2019
StitchKit
K191317 · NBY
Origami Surgical
General & Plastic Surgery · 58d
Cleared Jul 12, 2019
iNtuition-Structural Heart Module
K191585 · LLZ
Terarecon,Inc.
Radiology · 28d
Cleared Jul 12, 2019
Valleylab FT10 Electrosurgical Platform
K191601 · GEI
Covidien
General & Plastic Surgery · 25d
Cleared Jul 11, 2019
ScopeFlow Pure(TM)
K181418 · OCX
Partnership Medical Limited
Gastroenterology & Urology · 406d
Cleared Jul 11, 2019
EndoStream(TM)
K181457 · OCX
Partnership Medical Limited
Gastroenterology & Urology · 402d
Cleared Jul 11, 2019
GC FujiCEM 2 (Improved)
K182854 · EMA
GC America, Inc.
Dental · 274d
Cleared Jul 11, 2019
Stryker PEEK Customized Cranial Implant Kit
K190229 · GWO
Stryker
Neurology · 156d
Cleared Jul 11, 2019
Unifi Workspace v1.0.0
K190694 · LLZ
Hologic, Inc.
Radiology · 115d