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
4609–4632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2025
Argo Knotless GENESYS Anchor
K244025 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · HAW
Brainlab AG
Neurology · 60d
Cleared Jan 28, 2025
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · FRC
3M Company
General Hospital · 77d
Cleared Jan 28, 2025
Medical Monitor (27HS714S)
K243439 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 83d
Cleared Jan 28, 2025
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB,...
K243423 · OHS
Shenzhen Rainbow Technology Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jan 28, 2025
HemosIL CL HIT-IgG(PF4-H)
K243374 · LCO
Instrumentation Laboratory (IL) Co.
Hematology · 90d
Cleared Jan 27, 2025
Symani Surgical System (820-03830)
K250014 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 25d
Cleared Jan 27, 2025
Bunkerhill AVC
K243229 · JAK
BunkerHill Health
Radiology · 111d
Cleared Jan 27, 2025
CO2 Laser Therapy Systems (SHE-LSP003-1)
K242941 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 124d
Cleared Jan 27, 2025
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · KPS
Raysolution Healthcare Co., Ltd.
Radiology · 266d
Cleared Jan 27, 2025
Firstar Dental Unit
K231297 · EIA
Firstar Dental Company
Dental · 634d
Cleared Jan 24, 2025
MAGENTIQ-COLO (ME-APDS)
K244023 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 28d
Cleared Jan 24, 2025
AxCess® Expandable Interbody System
K243739 · MAX
Elliquence, LLC
Orthopedic · 51d
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