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
5041–5064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 08, 2025
QIAstat-Dx GI Panel 2 Mini B&V
K243813 · PCH
QIAGEN GmbH
Microbiology · 28d
Cleared Jan 08, 2025
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K243644 · JFB
Ceragem Co., Ltd.
Physical Medicine · 43d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842 · MSX
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Jan 08, 2025
ACE Cannula
K242741 · FMI
Ace Medical Industry Co., Ltd.
General Hospital · 119d
Cleared Jan 08, 2025
TRI-matrix® X-Force Implants
K242661 · DZE
Tri Dental Implants Int. AG
Dental · 126d
Cleared Jan 08, 2025
DormoTech NLab
K242290 · MNR
Dormotech Medical, Ltd.
Neurology · 159d
Cleared Jan 08, 2025
Sperm Freezing Medium
K242043 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 180d
Cleared Jan 08, 2025
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
K241806 · QOF
Life Technologies Corporation
Microbiology · 201d
Cleared Jan 08, 2025
ReminGel
K241489 · LBH
Inter-Med, Inc.
Dental · 229d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 08, 2025
Electrical Scooter, WT-T4SU
K240590 · INI
W'U'S Tech Co., Ltd.
Physical Medicine · 313d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Jan 07, 2025
MASADA Modular Spinal Fixation System
K243259 · NKB
Astura Medical
Orthopedic · 84d