Search FDA 510(k) Devices

5,468 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1585–1608 of 3,225
Cleared Jul 02, 2025
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · BTT
Medline Industries, LP
Anesthesiology · 149d
Cleared Jul 02, 2025
RC-SwiftPrep
K250279 · KJJ
Belport Company, Inc., Gingi-Pak
Dental · 152d
Cleared Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868 · LPL
Pegavision Corporation
Ophthalmic · 197d
Cleared Jul 02, 2025
AuroLase® System
K243701 · GEX
Nanospectra Biosciences, Inc.
General & Plastic Surgery · 215d
Cleared Jul 02, 2025
Compressor Nebulizer (NB-1100)
K243468 · CAF
Joytech Healthcare Co. , Ltd.
Anesthesiology · 236d
Cleared Jul 02, 2025
Boehringer Laboratories Liver Retractor
K243399 · GCJ
Boehringer Laboratories, LLC
General & Plastic Surgery · 244d
Cleared Jul 01, 2025
SnugFit ASA Extension
K251933 · MBI
Medacta International S.A.
Orthopedic · 7d
Cleared Jul 01, 2025
Momentum® Posterior Spinal Fixation System
K251719 · NKB
Ulrich Medical USA, Inc.
Orthopedic · 27d
Cleared Jul 01, 2025
Arthrex iBalance Partial Knee System
K251453 · HSX
Arthrex, Inc.
Orthopedic · 50d
Cleared Jul 01, 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · LJS
Access Vascular, Inc.
General Hospital · 74d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
K250699 · EZD
Convatec
Gastroenterology & Urology · 116d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221 · POK
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204 · FET
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Jul 01, 2025
Felix NeuroAI System
K250096 · QBC
Fasikl Incorporated
Neurology · 168d
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jul 01, 2025
SonoMSK
K243690 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 214d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 30, 2025
Otsuka Digital Feedback Device
K251088 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 82d
Cleared Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07,...
K251000 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 90d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · MAX
Carlsmed, Inc.
Orthopedic · 91d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d