Search FDA 510(k) Devices

5,452 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1297–1320 of 3,225
Cleared Aug 05, 2025
iPETcertum (v1.0)
K244016 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 221d
Cleared Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors...
K251762 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 56d
Cleared Aug 04, 2025
HnX-P1, HnX-PB
K251223 · IZL
H&abyz Co., Ltd.
Radiology · 105d
Cleared Aug 04, 2025
Terragene® Bionova® BT20 Biological Indicator
K251122 · FRC
Terragene
General Hospital · 115d
Cleared Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Aug 04, 2025
Blood Volume Analyzer (200)
K251087 · JWO
Daxor Corporation
Hematology · 117d
Cleared Aug 04, 2025
CUTIVA™ Topical Skin Adhesive (RM1700)
K250950 · MPN
Okapi Medical, LLC Dba Resivant Medical
General & Plastic Surgery · 129d
Cleared Aug 01, 2025
eZSURE™ Empty Fluid Container
K252094 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared Aug 01, 2025
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
K251707 · OHT
Shenzhen Huachuangtong Industrial...
General & Plastic Surgery · 59d
Cleared Aug 01, 2025
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope,...
K251652 · FAJ
American Medical Endoscopy, Inc.
Obstetrics & Gynecology · 64d
Cleared Aug 01, 2025
NOBILCAM IMPAK Disc
K251252 · MQC
Shandong Huge Dental Material...
Dental · 100d
Cleared Aug 01, 2025
Revolution Vibe
K250941 · JAK
Ge Medical Systems, LLC
Radiology · 126d
Cleared Aug 01, 2025
INNOVISION-DXII
K250790 · KPR
Dk Medical Systems Co., Ltd.
Radiology · 140d
Cleared Aug 01, 2025
Self-Forming Magnet (Flexagon Plus OTOLoc)
K250541 · SAH
GI Windows, Inc.
General & Plastic Surgery · 158d
Cleared Aug 01, 2025
AK 98 Dialysis Machine (955607)
K250508 · KDI
Vantive US Healthcare, LLC
Gastroenterology & Urology · 161d
Cleared Aug 01, 2025
MINI VP1 (PL67_F)
K250495 · LRX
Avizor S.A.
Ophthalmic · 162d
Cleared Aug 01, 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · IYO
DeepSight Technology, Inc.
Radiology · 171d
Cleared Aug 01, 2025
RONAVIS – FX (FX-001)
K250315 · HTY
AIRS, Inc.
Orthopedic · 178d
Cleared Aug 01, 2025
Sparta Infusion Set for Insulin
K243841 · FPA
Deka Research and Development
Chemistry · 231d
Cleared Aug 01, 2025
MycoMEIA Aspergillus Assay
K243496 · NOM
Pearl Diagnostics, Inc.
Microbiology · 262d
Cleared Aug 01, 2025
Access hsTnI
K243483 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Aug 01, 2025
Diazyme Colorimetric Lithium Assay
K243462 · NDW
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Aug 01, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243458 · LJS
Access Vascular, Inc.
General Hospital · 266d
Cleared Aug 01, 2025
Equinoxe® Shoulder System
K243448 · PHX
Exactech, Inc.
Orthopedic · 267d