FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
4897–4920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2025
ClearPoint System (Software Version 3.0)
K243657 · HAW
ClearPoint Neuro, Inc.
Neurology · 58d
Cleared Jan 24, 2025
Bone Marrow Biopsy Needle
K242322 · KNW
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 171d
Cleared Jan 24, 2025
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/...
K241793 · KNW
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 217d
Cleared Jan 24, 2025
OrganProtex HTK Solution
K241239 · KDL
Bridge TO Life, Ltd.
Gastroenterology & Urology · 266d
Cleared Jan 24, 2025
Galen™ Second Read™
K241232 · QPN
Ibex Medical Analytics , Ltd.
Pathology · 267d
Cleared Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · DFC
Roche Diagnostics Operations
Chemistry · 268d
Cleared Jan 24, 2025
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY )
K241107 · PBX
Indiba S. A. U.
General & Plastic Surgery · 277d
Cleared Jan 24, 2025
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
K241057 · NHN
Wuhan Guangdun Technology Co.,Ltd..
Physical Medicine · 281d
Cleared Jan 23, 2025
ProLift Pivot Expandable Spacer System
K243668 · MAX
Life Spine, Inc.
Orthopedic · 57d
Cleared Jan 23, 2025
Acu-Sinch Knotless Mini
K243624 · HTN
Acumed, LLC
Orthopedic · 59d
Cleared Jan 23, 2025
MONARCH™ Platform (MON-000008)
K243219 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 23, 2025
TeraRecon Aorta.CT (1.1.0)
K243158 · QIH
Terarecon,Inc.
Radiology · 115d
Cleared Jan 23, 2025
Mobility Scooter (S-01)
K242714 · INI
Zhejiang Seedream Medical Equipment...
Physical Medicine · 135d
Cleared Jan 23, 2025
CephNinja
K241819 · LLZ
Cyncronus, LLC
Radiology · 213d
Cleared Jan 23, 2025
Vios Monitoring System(TM) Model 2050
K241728 · DXN
Murata Vios, Inc.
Cardiovascular · 223d
Cleared Jan 23, 2025
RF Cannula
K241367 · GXI
Shanghai Samedical & Plastic...
Neurology · 254d
Cleared Jan 23, 2025
OTS 25-L (100-5)
K241234 · MBI
Ots Medical , Ltd.
Orthopedic · 266d
Cleared Jan 23, 2025
Rotatable Connector (5944RL)
K241199 · LDF
Shenzhen Launch Electrical Co., Ltd.
Cardiovascular · 268d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Jan 22, 2025
Nicolet EDX
K243982 · GWF
Natus Neurology Incorporated
Neurology · 30d
Cleared Jan 22, 2025
EMPHASYS Acetabular System
K243977 · LPH
Depuy Ireland UC
Orthopedic · 30d
Cleared Jan 22, 2025
ZeroClear™ Bag Access (423100)
K243976 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jan 22, 2025
Rapid Neuro3D
K243350 · QIH
Ischemaview, Inc.
Radiology · 86d
Cleared Jan 22, 2025
Reverso Pro System
K243139 · GEI
Indiba S. A. U.
General & Plastic Surgery · 114d