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: 2026–2026 ×
1,642 results
673–696 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 23, 2026
Introducer Sheath Set
K254248 · DYB
Cardiocycle Medical(Suzhou) Co., Ltd.
Cardiovascular · 115d
Cleared Apr 23, 2026
CCI PACS VIEWER (PACS-US-001)
K254237 · LLZ
CliniComp, Intl.
Radiology · 115d
Cleared Apr 23, 2026
ARTIS genio floor
K253752 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 149d
Cleared Apr 23, 2026
Liberant™ RX Aspiration Catheter
K253589 · QEZ
Medtronic Interventional Vascular, Inc.
Cardiovascular · 157d
Cleared Apr 23, 2026
ProBeam 360 Proton Therapy System v3.0
K252815 · LHN
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Apr 23, 2026
Tula Tympanostomy Tube Delivery Device
K252436 · ETD
Tusker Medical, Inc.
Ear, Nose, Throat · 265d
Cleared Apr 23, 2026
OxyGo Portable Oxygen Concentrator (1400-7000)
K252407 · CAW
Mv Life, LLC
Anesthesiology · 266d
Cleared Apr 23, 2026
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K252389 · DSH
Smwmed, Inc.
Cardiovascular · 266d
Cleared Apr 23, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Apr 22, 2026
corra™ cervical plating system
K260570 · KWQ
Carlsmed, Inc.
Orthopedic · 62d
Cleared Apr 22, 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · HGX
Jiangxi AOV Maternity & Baby Products...
Obstetrics & Gynecology · 86d
Cleared Apr 22, 2026
Mobility Scooter (X-12, X-14, X-17)
K260237 · INI
Wuyi Aichi Industry and Trade Co., Ltd.
Physical Medicine · 86d
Cleared Apr 22, 2026
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
K260150 · OHS
NOOANCE
General & Plastic Surgery · 92d
Cleared Apr 22, 2026
VANISH PRO
K253765 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 148d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 22, 2026
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 205d
Cleared Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K253163 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 208d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM...
K252306 · QVB
Steritec Products
General Hospital · 272d
Cleared Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · MBI
Tigon Medical
Orthopedic · 33d
Cleared Apr 21, 2026
EvoEndo Single-Use Endoscopy System
K260573 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 21, 2026
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371,...
K260518 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 63d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d