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
4753–4776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2025
Erchonia Zerona® VZ8
K243811 · OLI
Erchonia Corporation
General & Plastic Surgery · 30d
Cleared Jan 10, 2025
Safety Winged Blood Collection Sets
K243806 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 30d
Cleared Jan 10, 2025
Ulike Reglow Light Therapy Device (UM10)
K243492 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 59d
Cleared Jan 10, 2025
Universal Tendon Spacer
K243477 · HXA
Askorn Medical
Orthopedic · 63d
Cleared Jan 10, 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195 · HWC
Arthrex, Inc.
Orthopedic · 101d
Cleared Jan 10, 2025
Bowhead ERA Wheelchairs
K243111 · IOR
Bowhead Design Corp.
Physical Medicine · 102d
Cleared Jan 10, 2025
ZZIREN™ Orogastric Tube
K242901 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 109d
Cleared Jan 10, 2025
BioCode Gastrointestinal Pathogen Panel (GPP)
K242877 · PCH
Applied BioCode, Inc.
Microbiology · 109d
Cleared Jan 10, 2025
Safecare Urinary Tract Infection Test
K242767 · JMT
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 119d
Cleared Jan 10, 2025
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269,...
K242528 · DXN
Shenzhen Ruiankang Technology Co., Ltd.
Cardiovascular · 137d
Cleared Jan 10, 2025
OverCEM SA Universal
K242366 · EMA
Overfibers S.R.L.
Dental · 154d
Cleared Jan 10, 2025
Triopsy Actuator (TMSDGB)
K242228 · KNW
Triopsy Medical, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 10, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K242071 · QOF
Cepheid
Microbiology · 178d
Cleared Jan 10, 2025
ScreenDx
K241891 · QWO
Imvaria, Inc.
Radiology · 196d
Cleared Jan 10, 2025
Solo Pace Control
K241781 · DTE
Solo Pace, Inc.
Cardiovascular · 204d
Cleared Jan 10, 2025
Mould Probe MR Safe
K241764 · JAQ
Varian Medical Systems, Inc.
Radiology · 204d
Cleared Jan 10, 2025
TriVerity
K241676 · PRE
Inflammatix, Inc.
Microbiology · 213d
Cleared Jan 10, 2025
INTRABEAM (700)
K241174 · JAD
Carl Zeiss Meditec, AG
Radiology · 259d
Cleared Jan 10, 2025
Unscented Tampon
K241064 · HEB
Shandong Intco Hygiene Products Co.,...
Obstetrics & Gynecology · 267d
Cleared Jan 10, 2025
PeriCALM Patterns 3.0
K241009 · HGM
Perigen, Inc.
Obstetrics & Gynecology · 273d
Cleared Jan 10, 2025
Klaxon (Twist)
K240267 · ITI
Klaxon Mobility GmbH
Physical Medicine · 345d
Cleared Jan 09, 2025
Dental Cone-beam Computed Tomography (FinScan F350)
K242805 · OAS
Changzhou Finno Medical Technology...
Radiology · 114d
Cleared Jan 09, 2025
FullFocus
K241273 · QKQ
Paige.Ai, Inc.
Pathology · 248d
Cleared Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K243818 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 27d