Search FDA 510(k) Database

7,037 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19369–19392 of 174,061
Cleared Jan 06, 2020
RS85 Diagnostic Ultrasound System
K192903 · IYN
Samsung Medison Co., Ltd.
Radiology · 83d
Cleared Jan 06, 2020
ViewPoint 6
K192917 · LLZ
Ge Medical Systems Ultrasound And
Radiology · 83d
Cleared Jan 06, 2020
MRIaudio PREM System with MRIview
K193102 · LNH
Mriaudio, Inc.
Radiology · 59d
Cleared Jan 06, 2020
R2P Destination Slender Guiding Sheath
K193125 · DYB
Terumo Medical Corporation
Cardiovascular · 55d
Cleared Jan 05, 2020
TriMed ASET Foot Plating System
K192696 · HRS
TriMed, Inc.
Orthopedic · 101d
Cleared Jan 03, 2020
Dillard Nasal Balloon Catheter
K181546 · LRC
Intuit Medical Products, LLC
Ear, Nose, Throat · 570d
Cleared Jan 03, 2020
Z5-BL
K190243 · DZE
Z-Systems AG
Dental · 331d
Cleared Jan 03, 2020
Endotics
K190669 · FDF
Era Endoscopy S.R.L.
Gastroenterology & Urology · 294d
Cleared Jan 03, 2020
Conformity stem, cemented
K191056 · JDI
United Orthopedic Corporation
Orthopedic · 259d
Cleared Jan 03, 2020
PiccGuard
K191195 · PZW
Piccguard, LLC
General Hospital · 245d
Cleared Jan 03, 2020
PALLAS 308/311 Solid-State UV Laser System
K191501 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 211d
Cleared Jan 03, 2020
Straumann Ceramic Healing Abutments
K192893 · NHA
Institut Straumann AG
Dental · 84d
Cleared Jan 03, 2020
Flex Body SPEEDER
K193140 · MOS
Quality Electrodynamics, LLC
Radiology · 51d
Cleared Jan 03, 2020
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K193239 · LRK
Mpowrx Health and Wellness Products...
Dental · 39d
Cleared Jan 03, 2020
SureMAX Family of Cervical Spacers
K193359 · ODP
Additive Implants, Inc.
Orthopedic · 30d
Cleared Jan 03, 2020
NeuroBlate System
K193375 · GEX
Monteris Medical,
Neurology · 29d
Cleared Jan 03, 2020
AlignRT Plus
K193431 · IYE
Vision Rt, Ltd.
Radiology · 24d
Cleared Jan 02, 2020
Air Next
K183089 · BZG
Nuvoair AB
Anesthesiology · 422d
Cleared Jan 02, 2020
Optilume Basic Urological Balloon Dilation Catheter
K191061 · KOE
Urotronic, Inc.
Gastroenterology & Urology · 255d
Cleared Jan 02, 2020
OC-Auto SENSOR io iFOB Test
K191147 · OOX
Eiken Chemical Co., Ltd.
Hematology · 247d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 216d
Cleared Jan 02, 2020
Sterile LeadConfirm
K191739 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 188d
Cleared Jan 02, 2020
OptoWire III
K191907 · DQX
Opsens, Inc.
Cardiovascular · 170d
Cleared Jan 02, 2020
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
K192216 · ITI
Invacare Corporation
Physical Medicine · 140d