Search FDA 510(k) Devices

5,462 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1489–1512 of 3,225
Cleared Jul 11, 2025
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
K251472 · HBW
Inion OY
Neurology · 59d
Cleared Jul 11, 2025
ResiCem EX
K251470 · EMA
Shofu Dental Corporation
Dental · 59d
Cleared Jul 11, 2025
Resolve Anterior Cervical Plate System
K251436 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 64d
Cleared Jul 11, 2025
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and...
K251352 · BSZ
Codonics.Incorporated
Anesthesiology · 72d
Cleared Jul 11, 2025
BD Cathena™ Safety IV Catheter
K251155 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 88d
Cleared Jul 11, 2025
AviClear Laser System
K251149 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Jul 11, 2025
RipCord
K251134 · HTN
TriMed, Inc.
Orthopedic · 91d
Cleared Jul 11, 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K250942 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 105d
Cleared Jul 11, 2025
Disposable Trocars
K250820 · GCJ
Sinolinks Medical Innovation, Inc.
General & Plastic Surgery · 115d
Cleared Jul 11, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional...
K250772 · NLH
Surgical Instrument Service and...
Cardiovascular · 120d
Cleared Jul 11, 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · ITX
Olympus Medical Systems Corporation
Radiology · 120d
Cleared Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 120d
Cleared Jul 11, 2025
FreeStyle Comfort (AS200 / FreeStyle Comfort)
K250671 · CAW
Caire, Inc.
Anesthesiology · 128d
Cleared Jul 11, 2025
Ceragem Automatic Thermal Massager (CGM MB-2401)
K250266 · JFB
Ceragem Co., Ltd.
Physical Medicine · 162d
Cleared Jul 11, 2025
Choice 2 DC
K250156 · EMA
Bisco, Inc.
Dental · 171d
Cleared Jul 11, 2025
Natural rubber latex male condom
K250034 · HIS
Shaoguan Regenex Pharmaceuticals Co.,...
Obstetrics & Gynecology · 185d
Cleared Jul 11, 2025
TurbAlign
K243655 · LYA
Spirair, Inc.
Ear, Nose, Throat · 227d
Cleared Jul 11, 2025
Disposable Biopsy Needle
K243296 · KNW
Carbon (Shenzhen) Medical Device Co.,...
General & Plastic Surgery · 266d
Cleared Jul 11, 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B...
K243274 · OZE
Centers For Disease Control and...
Microbiology · 268d
Cleared Jul 11, 2025
B-Scan
K243227 · IYO
Accutome, Inc. Doing Business AS...
Radiology · 276d
Cleared Jul 11, 2025
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K241179 · QYX
Vivaquant, Inc.
Cardiovascular · 438d
Cleared Jul 10, 2025
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
K251945 · HRS
TriMed, Inc.
Orthopedic · 15d
Cleared Jul 10, 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · MRW
Providence Medical Technology, Inc.
Orthopedic · 20d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d