Search FDA 510(k) Devices

5,444 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1321–1344 of 3,347
Cleared Aug 18, 2023
P200TE (A10700)
K231673 · OBO
Optos Plc.
Ophthalmic · 71d
Cleared Aug 18, 2023
SPARK Scan
K231457 · GWQ
Spark Neuro, Inc.
Neurology · 91d
Cleared Aug 18, 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia...
K231262 · HRS
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Pangea Utility Plating System, Pangea Platform
K231257 · HRS
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Cochlear™ Osia® System
K231204 · PFO
Cochlear
Ear, Nose, Throat · 113d
Cleared Aug 18, 2023
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096 · KPM
Pleural Dynamics, Inc.
Gastroenterology & Urology · 122d
Cleared Aug 18, 2023
1.5T HD T/R Knee Array (10-F34127)
K231085 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 123d
Cleared Aug 18, 2023
Unicare (K-UNICARE-USA)
K231053 · NUH
Tenscare, Ltd.
Neurology · 127d
Cleared Aug 18, 2023
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the...
K231026 · PGY
Shenzhen Beacon Display Technology...
Radiology · 129d
Cleared Aug 18, 2023
Smart Wedge algorithm
K230579 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 169d
Cleared Aug 18, 2023
Daye Tampon
K223883 · HEB
Annes Daye, Ltd.
Obstetrics & Gynecology · 234d
Cleared Aug 18, 2023
IDS ACTH II
K223867 · CKG
Immunodiagnostic Systems Limited
Chemistry · 238d
Cleared Aug 18, 2023
Onera Sleep Test System (Onera STS)
K223573 · MNR
Onera B.V.
Neurology · 261d
Cleared Aug 18, 2023
Dreem 3S
K223539 · OLZ
Beacon Biosignals, Inc.
Neurology · 268d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite...
K223526 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Aug 18, 2023
Sleepiz One+
K223163 · DRT
Sleepiz AG
Cardiovascular · 315d
Cleared Aug 18, 2023
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim,...
K222993 · KGO
Sentienx Sdn Bhd
General Hospital · 324d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253 · NHA
Dio Corporation
Dental · 564d
Not Cleared Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
DEN230019 · QXH
Boston Scientific Corporation
Gastroenterology & Urology · 144d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · QOF
Cepheid
Microbiology · 86d
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
DRTECH Corporation
Radiology · 140d
Cleared Aug 17, 2023
Tandry Locking Plate System
K230690 · HRS
Microware Precision Co., Ltd.
Orthopedic · 157d
Cleared Aug 17, 2023
Aer-O-Scope Colonoscope System
K230588 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 168d
Cleared Aug 17, 2023
Cadwell Guardian
K230415 · GWF
Cadwell Industries, Inc.
Neurology · 182d