Search FDA 510(k) Devices

5,493 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2017–2040 of 3,225
Cleared May 21, 2025
MotiliCap GI Monitoring System
K250493 · NYV
Anx Robotica Corporation
Gastroenterology & Urology · 90d
Cleared May 21, 2025
InVision Precision Cardiac Amyloid
K243866 · SDJ
Invision Medical Technology Corporation
Cardiovascular · 155d
Cleared May 21, 2025
EPIQ Series Diagnostic Ultrasound System
K243793 · IYN
Philips Ultrasound, LLC
Radiology · 162d
Cleared May 21, 2025
Synapse 3D Base Tools (V7.0)
K243762 · QIH
Fujifilm Corporation
Radiology · 166d
Cleared May 21, 2025
HJY VisualNext 3D Endoscopic Vision System
K243429 · GWG
Hjy Smart Medical Device Co., Ltd.
Neurology · 197d
Cleared May 21, 2025
3DMatrix DynaFlex (DynaFlex)
K243302 · OXF
Printbio, Inc.
General & Plastic Surgery · 215d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 21, 2025
FlareHawk Interbody Fusion System
K243116 · MAX
Integrity Implants Inc. Dba Accelus
Orthopedic · 233d
Cleared May 21, 2025
ClearHemograsper
K242857 · KGE
Finemedix Co., Ltd.
Gastroenterology & Urology · 243d
Cleared May 21, 2025
MEM Clear Aligner System
K242637 · NXC
Mem Dental Technology Co., Ltd.
Dental · 260d
Cleared May 21, 2025
The Karma® Fixation System
K242527 · MRW
Spinal Elements, Inc.
Orthopedic · 268d
Cleared May 20, 2025
ViewFlex™ X ICE Catheter, Sensor Enabled™
K251231 · OBJ
Abbott Medical
Cardiovascular · 28d
Cleared May 20, 2025
Sovereign Posterior Cervical System
K250866 · NKG
Met One Technologies, LLC
Orthopedic · 57d
Cleared May 20, 2025
X-PAC® N-GAGE™ Lumbar Plate System
K250602 · KWQ
Expanding Innovations, Inc.
Orthopedic · 81d
Cleared May 20, 2025
Biomic Color Opaque
K250534 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 85d
Cleared May 20, 2025
FP3D
K250489 · EBI
Keystone Industries
Dental · 90d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared May 20, 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U)
K250243 · BTR
Flexicare Medical Limited.
Anesthesiology · 113d
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared May 20, 2025
EveryWare
K242485 · MOD
Breas Medical AB
Anesthesiology · 272d
Cleared May 19, 2025
Dentemp Pro-Comfort Dental Guard
K250456 · OBR
Doc Brands, Inc.
Dental · 90d
Cleared May 19, 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4...
K250447 · LON
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 19, 2025
CloSYS® Dry Mouth Sensitive Mouth Rinse
K250390 · LFD
Rowpar Pharmaceuticals, Inc.
Dental · 97d
Cleared May 19, 2025
SleepRight Snore Aid
K250122 · LRK
Splintek, Inc.
Dental · 122d