Search FDA 510(k) Devices

5,426 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1033–1056 of 3,347
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
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336 · QVR
T2biosystems, Inc.
Microbiology · 130d
Cleared Sep 15, 2023
Perifix FX Catheter
K231242 · BSO
B.Braun Medical, Inc.
Anesthesiology · 137d
Cleared Sep 15, 2023
LW UCLA Abutment
K231235 · NHA
Ossvis Co., Ltd.
Dental · 140d
Cleared Sep 15, 2023
NIDO™ Pedicle Screw System
K230974 · NKB
Kalitec Medical
Orthopedic · 163d
Cleared Sep 15, 2023
Accelerate Compression Screw System-Small Product Code ACC-S
K230946 · HWC
Trax Surgical
Orthopedic · 164d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 182d
Cleared Sep 15, 2023
Ambu® aScope™ Colon
K230332 · FDF
Ambu A/S
Gastroenterology & Urology · 220d
Cleared Sep 15, 2023
Carnation series Diagnostic Ultrasound System
K230066 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 249d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Sep 15, 2023
Sensis Vibe (VD15)
K223812 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 269d
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource...
K223788 · FOZ
Medsource International, LLC
General Hospital · 270d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610 · JZO
Roche Diagnostics
Immunology · 382d
Cleared Sep 15, 2023
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead...
K221860 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 445d
Cleared Sep 15, 2023
Access Thyroglobulin
K220972 · MSW
Beckman Coulter, Inc.
Immunology · 529d
Cleared Sep 15, 2023
Avologi Gel Primer (Model: Av25)
K220735 · GYB
Premier North America, Inc.
Neurology · 550d
Cleared Sep 14, 2023
LightForce Orthodontic System
K232827 · NJM
Lightforce Orthodontics
Dental · 1d