Search FDA 510(k) Devices

5,503 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2185–2208 of 3,225
Cleared May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457 · FRO
Seriously Clean, Ltd.
General & Plastic Surgery · 176d
Cleared May 02, 2025
SQA-iOw Sperm Quality Analyzer
K243114 · POV
Medical Electronic Systems , Ltd.
Hematology · 214d
Cleared May 02, 2025
LUMYS (V1)
K243069 · LLZ
Intradys
Radiology · 217d
Cleared May 02, 2025
Origin™ Cemented Hip Stem
K243043 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared May 02, 2025
SpO2 Extension Cable
K242986 · DSA
Beijing Rongrui-Century Science &...
Anesthesiology · 218d
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763 · FPA
Pfm Medical, Inc.
General Hospital · 232d
Cleared May 02, 2025
AT-Patch (ATP-C130/ATP-C70)
K242583 · DSH
Atsens Co., Ltd.
Cardiovascular · 245d
Cleared May 01, 2025
APRO 45 Catheter
K251014 · DQY
Alembic, LLC
Neurology · 29d
Cleared May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,...
K251007 · DXF
Circa Scientific, Inc.
Cardiovascular · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250995 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
APEX 3D Total Ankle Replacement System
K250641 · HSN
Paragon 28, Inc.
Orthopedic · 58d
Cleared May 01, 2025
Disposable Distal Attachment D-201 Series
K250296 · FDS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 01, 2025
Vscan Air
K250087 · IYN
GE Medical Systems Ultrasound and...
Radiology · 107d
Cleared May 01, 2025
ONE TRAY® Sealed Sterilization Container System
K250029 · KCT
Innovative Sterilization Technologies
General Hospital · 115d
Cleared May 01, 2025
Wrinkle Treatment Device (JM1, JM2B)
K244020 · OHS
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 125d
Cleared May 01, 2025
X°Port Lung Preservation System
K243870 · KDN
Traferox Technologies, Inc.
Gastroenterology & Urology · 135d
Cleared May 01, 2025
Conical Ti Base abutments
K243521 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared May 01, 2025
Resolve Modular Revision Hip Stem
K242315 · MEH
United Orthopedic Corporation
Orthopedic · 269d
Cleared Apr 30, 2025
AuST Steerable Sheath
K251051 · DYB
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Apr 30, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K251024 · JPA
Haemonetics
Hematology · 28d
Cleared Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
K251015 · NRY
Alembic, LLC
Neurology · 28d
Cleared Apr 30, 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 35d
Cleared Apr 30, 2025
Resolve Fundus Camera
K250683 · HKI
Optain Health, Inc.
Ophthalmic · 55d