Search FDA 510(k) Database

6,433 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8041–8064 of 174,061
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
Cleared Sep 14, 2023
Provecta 3D Prime and Provecta 3D Prime Ceph
K232487 · OAS
Durr Dental SE
Radiology · 28d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462 · LHQ
Usa Therm, Inc.
Radiology · 30d
Cleared Sep 14, 2023
OrionXR
K232189 · LLZ
Hoth Intelligence, Inc.
Radiology · 52d
Cleared Sep 14, 2023
Anovo Pedestal
K232146 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 57d
Cleared Sep 14, 2023
IPL Hair Removal, Model: W-1095, W-1098
K232124 · OHT
Shenzhen Wochuan Electronic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Sep 14, 2023
cNeuro cPET
K231576 · KPS
Combinostics OY
Radiology · 106d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484 · MMK
Pureway Compliance, Inc.
General Hospital · 114d