Search FDA 510(k) Database

6,431 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8017–8040 of 174,061
Cleared Sep 19, 2023
Aquilion Serve (TSX-307A/1) V1.3
K231281 · JAK
Canon Medical Systems Corporation
Radiology · 139d
Cleared Sep 19, 2023
Accuject Refra Injector AR2900
K231106 · MSS
Medicel AG
Ophthalmic · 153d
Cleared Sep 19, 2023
angiOCCLUDE Ligating Clips
K230966 · FZP
A2 Medical Systems, LLC
General & Plastic Surgery · 167d
Cleared Sep 19, 2023
Q Distal Access Catheter
K222948 · QJP
Mivi Neuroscience, Inc.
Neurology · 357d
Cleared Sep 19, 2023
AI100 with Shonit
K221309 · JOY
Sigtuple Technologies Pvt. , Ltd.
Hematology · 502d
Cleared Sep 18, 2023
Apollo ESG NXT System, Apollo REVISE NXT System
K232544 · QTD
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 18, 2023
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K232530 · OVD
Nexus Spine, LLC
Orthopedic · 28d
Cleared Sep 18, 2023
X-Twist Biocomposite Suture Anchor
K232513 · MAI
Parcus Medical
Orthopedic · 31d
Cleared Sep 18, 2023
BTL-785BNF Handpiece
K232172 · NFO
BTL Industries, Inc.
Neurology · 59d
Cleared Sep 18, 2023
Access Myoglobin
K231832 · DDR
Beckman Coulter, Inc.
Chemistry · 88d
Cleared Sep 18, 2023
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K231663 · LRK
Innovative Health Technologies (Nz),...
Dental · 103d
Cleared Sep 18, 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201,...
K231367 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 130d
Cleared Sep 18, 2023
MA-40, MA-112
K223835 · FRF
Medify Air, LLC
General Hospital · 270d
Cleared Sep 18, 2023
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA...
K222251 · QXS
B.R.A.H.M.S GmbH, Part of Thermo Fisher
Immunology · 418d
Cleared Sep 16, 2023
ImPACT Version 4
K231688 · POM
Impact Applications, Inc.
Neurology · 99d
Cleared Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · CAH
Passy-Muir, Inc.
General Hospital · 205d
Cleared Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 28d
Cleared Sep 15, 2023
Catalyst Bone Void Filler
K232315 · MQV
Ossdsign AB
Orthopedic · 44d
Cleared Sep 15, 2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS
K232199 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 52d
Cleared Sep 15, 2023
Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S...
K232198 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 52d
Cleared Sep 15, 2023
Power wheelchair (Model:BC-EA8000)
K232121 · ITI
Ningbo Baichen Medical Devices Co., Ltd.
Physical Medicine · 60d
Cleared Sep 15, 2023
ClearPoint Array System (Version 1.2)
K232102 · HAW
ClearPoint Neuro, Inc.
Neurology · 63d
Cleared Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
K231827 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 86d
Cleared Sep 15, 2023
PENTO Nd:YAG and Alexandrite laser system
K231791 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 87d