FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2905–2928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2025
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology...
K243552 · JXG
Integra Lifesciences Production...
Neurology · 264d
Cleared Aug 06, 2025
Aevumed PHANTOM Suture Anchors
K242895 · MBI
Aevumed, Inc.
Orthopedic · 317d
Cleared Aug 05, 2025
AltiVate Reverse® Glenoid
K252141 · PHX
Encore Medical, L.P.
Orthopedic · 28d
Cleared Aug 05, 2025
PRADO™ Lumbar Interbody Fusion System
K252113 · MAX
Bethesda Medical Devices
Orthopedic · 29d
Cleared Aug 05, 2025
Chemfort Female Luer Lock Adaptor
K251411 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 05, 2025
Respiree Cardio- Respiratory Monitor System
K250934 · BZQ
Respiree Pte, Ltd.
Anesthesiology · 130d
Cleared Aug 05, 2025
trophon2
K250434 · OUJ
Nanosonics
General Hospital · 172d
Cleared Aug 05, 2025
uMR Jupiter
K250246 · LNH
Shanghai United Imaging Healthcare...
Radiology · 190d
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