Search FDA 510(k) Database

7,075 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
20185–20208 of 174,061
Cleared Oct 01, 2019
DIAMOND-5A/6A/8A
K192453 · KPR
DRGEM Corporation
Radiology · 22d
Cleared Sep 30, 2019
UF(II) Anatomic abutment
K190048 · NHA
Dio Corporation
Dental · 263d
Cleared Sep 30, 2019
SmileAlign Orthodontic Aligner System
K191774 · NXC
3D Global Biotech, Inc.
Dental · 90d
Cleared Sep 30, 2019
Fidmi Low Profile Enteral Feeding Device
K191844 · KGC
Fidmi Medical, Ltd.
Gastroenterology & Urology · 83d
Cleared Sep 30, 2019
APTUS Wrist Spanning Plates 2.5
K191848 · HRS
Medartis AG
Orthopedic · 82d
Cleared Sep 30, 2019
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
K192425 · OAP
Wontech Co., Ltd.
General & Plastic Surgery · 25d
Cleared Sep 29, 2019
Visalys Tooth Primer
K191524 · KLE
Kettenbach GmbH & Co. KG
Dental · 111d
Cleared Sep 27, 2019
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child,...
K180001 · MNR
Embla Systems
Anesthesiology · 633d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Precision Spine, Inc.
Orthopedic · 465d
Cleared Sep 27, 2019
XLR8 Abdominal Wound Dressing Kit
K182722 · OMP
Genadyne Biotechnologies
General & Plastic Surgery · 364d
Cleared Sep 27, 2019
Smart-C
K190024 · OXO
Turner Imaging Systems, Inc.
Radiology · 263d
Cleared Sep 27, 2019
CEREC Guides
K190059 · NDP
Dentsply Sirona
Dental · 259d
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and...
K190076 · OYX
Cepheid
Pathology · 254d
Cleared Sep 27, 2019
Sorrento Bone Graft Substitute
K191074 · MQV
Xenco Medical, LLC
Orthopedic · 157d
Cleared Sep 27, 2019
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with...
K191444 · DTZ
Medtronic, Inc.
Cardiovascular · 119d
Cleared Sep 27, 2019
Radiance 330 Proton Beam Therapy System
K191521 · LHN
Protom International Holding Corporation
Radiology · 112d
Cleared Sep 27, 2019
FUJIFILM Duodenoscope Model ED-580XT
K191747 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 88d
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · JWY
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 27, 2019
FlexBand Plus
K192112 · FTL
International Life Sciences
General & Plastic Surgery · 53d
Cleared Sep 27, 2019
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact...
K192129 · LPL
Clearlab SG Pte, Ltd.
Ophthalmic · 51d
Cleared Sep 27, 2019
MiniMAX
K192352 · LZO
Medacta International S.A.
Orthopedic · 29d
Cleared Sep 27, 2019
CATSmart
K192368 · CAC
Fresenius Kabi AG
Cardiovascular · 28d
Cleared Sep 27, 2019
EpiFaith Syringe
K192421 · FMF
Flat Medical Co., Ltd.
Anesthesiology · 23d
Cleared Sep 26, 2019
Dia-Proseal
K182009 · KIF
DiaDent Group International
Dental · 426d