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
10201–10224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2023
Excella Navigation Instruments
K223511 · OLO
Innovasis, Inc.
Orthopedic · 161d
Cleared May 02, 2023
Zeolite Hemostatic Cotton
K223495 · QSY
Hangzhou Zeo-Innov Life Technology...
General & Plastic Surgery · 162d
Cleared May 02, 2023
ASEPT Peritoneal Drainage System
K221779 · PNG
Pfm Medical, Inc.
Gastroenterology & Urology · 315d
Cleared May 02, 2023
FortiShield (Biosynthetic Wound Matrix)
K212579 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 624d
Cleared May 01, 2023
CP620G LCD monitor, CP620 LCD monitor
K230643 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 54d
Cleared May 01, 2023
vPATCH
K223595 · QRC
Virility Medical , Ltd.
Gastroenterology & Urology · 150d
Cleared May 01, 2023
Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non...
K223182 · OIV
Worldwork S.R.L
Dental · 202d
Cleared May 01, 2023
RIA Safeguard
K222416 · FRF
Ria Tech Co., Ltd.
General Hospital · 264d
Cleared May 01, 2023
CarnaLife Holo
K221870 · LLZ
Medapp S.A.
Radiology · 307d
Cleared Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
K230972 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Apr 28, 2023
Hand Trauma Threaded Nail System
K230908 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 28d
Cleared Apr 28, 2023
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K230600 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 56d
Cleared Apr 28, 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · OAP
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 56d
Cleared Apr 28, 2023
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
K230480 · FZP
Teleflex Medical
General & Plastic Surgery · 65d
Cleared Apr 28, 2023
Bladeless Trocar – Artemis Lap Cannula
K230058 · GCJ
T.A.G. Medical Products Corporation,...
General & Plastic Surgery · 109d
Cleared Apr 28, 2023
Q-Rejuvalight Pro Facewear (Model: P19-0023)
K230042 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 112d
Cleared Apr 28, 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K223862 · OAP
Wontech Co., Ltd.
General & Plastic Surgery · 126d
Cleared Apr 28, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677 · NHA
Nobel Biocare AB
Dental · 141d
Cleared Apr 28, 2023
Customized Abutment
K223634 · NHA
Arum Dentistry Co., Ltd.
Dental · 144d
Cleared Apr 28, 2023
Nanox.ARC
K222934 · IZF
Nano-X Imaging , Ltd.
Radiology · 214d
Cleared Apr 28, 2023
ET Abutment System
K222636 · NHA
Hiossen, Inc.
Dental · 240d
Cleared Apr 28, 2023
INTEGRATE -C Interbody Fusion System
K222004 · ODP
Happe Spine
Orthopedic · 295d
Cleared Apr 28, 2023
BNLE Access Guidewire
K221390 · DQX
Biomerics Nle
Cardiovascular · 350d
Cleared Apr 28, 2023
Kurin Blood Culture Collection Set with Kurin Lock Technology
K220677 · JKA
Kurin, Inc.
General Hospital · 416d