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
5497–5520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2024
FREDDO
K242132 · GEX
Fabinject Lndustria E Comercio...
General & Plastic Surgery · 88d
Cleared Oct 18, 2024
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)
K241959 · FRC
3M Company
General Hospital · 107d
Cleared Oct 18, 2024
Mojo Full Face Vented Mask
K241830 · BZD
Sleepnet Corporation
Anesthesiology · 116d
Cleared Oct 18, 2024
Contour+ (MVision AI Segmentation)
K241490 · QKB
Mvision AI OY
Radiology · 147d
Cleared Oct 18, 2024
edelweiss CAD/CAM T-BLOCK
K241131 · EBF
Edelweiss Dentistry Products GmbH
Dental · 177d
Cleared Oct 18, 2024
Surgical Face Mask (Tie on/ Ear loops)
K240916 · FXX
Xiantao Daoqi Plastic Co., Ltd.
General Hospital · 198d
Cleared Oct 18, 2024
Spectral CT 7500 RT
K240844 · JAK
Philips Medical Systems Technologies...
Radiology · 205d
Cleared Oct 18, 2024
PreXolid CAD/CAM abutments
K240725 · NHA
Eclectic Co., Ltd.
Dental · 214d
Cleared Oct 18, 2024
Pixie Skin Tag
K240226 · ORE
Oystershell NV
General & Plastic Surgery · 266d
Cleared Oct 18, 2024
ABCcolla® Collagen ADM Scaffold
K233378 · KGN
Acro Biomedical Co., Ltd.
General & Plastic Surgery · 382d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 18, 2024
Vittra APS Unique Flow
K232994 · EBF
Dentscare Ltda
Dental · 392d
Cleared Oct 18, 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide...
K222944 · GAP
Safepath Medical, Inc.
General & Plastic Surgery · 753d
Cleared Oct 17, 2024
NOVA Minimally Invasive System
K242899 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 24d
Cleared Oct 17, 2024
Ascent Cardiorespiratory Diagnostic Software
K242809 · BTY
Medical Graphics Corporation
Anesthesiology · 30d
Cleared Oct 17, 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · OHT
Shenzhen Huaruibo Electric Appliances...
General & Plastic Surgery · 83d
Cleared Oct 17, 2024
Electrically powered wheelchair (HP202)
K241337 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 157d
Cleared Oct 17, 2024
Hidroxa SE30
K241267 · EGJ
Hidroxa Medical AB
Physical Medicine · 164d
Cleared Oct 17, 2024
SIGNA MAGNUS
K241242 · LNH
Ge Medical Systems, LLC
Radiology · 167d
Cleared Oct 17, 2024
Zipline Access Catheter
K240711 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · OMB
Epitel, Inc.
Neurology · 251d
Cleared Oct 17, 2024
MP Pin flat without thread (36BMP000020/MP20)
K240321 · DZL
Hager& Meisinger GmbH
Dental · 258d
Cleared Oct 17, 2024
Electric Breast Pump (F5055)
K240218 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 265d
Cleared Oct 17, 2024
EGPS Navigated Instruments
K240160 · OLO
Astura Medical
Orthopedic · 272d