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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13585–13608 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2022
CerusEndo Microcatheter (027)
K213314 · QJP
Cerus Endovascular, Inc.
Neurology · 162d
Cleared Mar 15, 2022
Peridot Spinal Interbody System
K213980 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 85d
Cleared Mar 14, 2022
Qitexio
K203738 · FMF
Medex
General Hospital · 447d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Arterys, Inc.
Radiology · 447d
Cleared Mar 14, 2022
2.4mm Distal Radius System
K211324 · HRS
Auxein Medical Private Limited
Orthopedic · 318d
Cleared Mar 14, 2022
Stasis Gel
K211420 · MVL
Belport Company, Inc., Gingi-Pak
Dental · 311d
Cleared Mar 14, 2022
Yadu Medical Face Mask (Level 1)
K212330 · FXX
Henan Yadu Industrial Co., Ltd.
General Hospital · 230d
Cleared Mar 14, 2022
OPN NC PTCA Dilatation Catheter
K212393 · LOX
Sis Medical AG
Cardiovascular · 224d
Cleared Mar 14, 2022
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
K213790 · IOR
Mobility Source Medical Technology...
Physical Medicine · 98d
Cleared Mar 14, 2022
DWFritz ASM2000
K213894 · FXX
Dwfritz Automation, Inc.
General Hospital · 90d
Cleared Mar 14, 2022
CareGUARD Sterilization Wrap
K213907 · FRG
Care Essentials Pty, Ltd.
General Hospital · 90d
Cleared Mar 14, 2022
BriefCase
K214043 · QFM
Aidoc Medical , Ltd.
Radiology · 81d
Cleared Mar 14, 2022
Optimotion Implants Porous Metal-Backed Patella
K220049 · MBH
Optimotion Implants, LLC
Orthopedic · 67d
Cleared Mar 12, 2022
Disposable Medical Face Mask
K213806 · FXX
Xiantao Zhibo Nonwoven Products Co.,...
General Hospital · 96d
Cleared Mar 11, 2022
Intai Anatomic Locking Plate and Screw System
K201229 · HRS
Intai Technology Corporation
Orthopedic · 673d
Cleared Mar 11, 2022
Maxima Surgical Gown
K201351 · FYA
Elevate Textiles
General Hospital · 659d
Cleared Mar 11, 2022
Dental Electric Motor
K202075 · EBW
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 592d
Cleared Mar 11, 2022
Minuteman G5 MIS Fusion Plate
K211880 · PEK
Spinal Simplicity, LLC
Orthopedic · 263d
Cleared Mar 11, 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
K211887 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 263d
Cleared Mar 11, 2022
RI.HIP MODELER
K212040 · LLZ
Blue Belt Technologies, Inc.
Radiology · 254d
Cleared Mar 11, 2022
DESS Dental Smart Solutions
K212628 · NHA
Terrats Medical SL
Dental · 204d
Cleared Mar 11, 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic...
K212920 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 178d
Cleared Mar 11, 2022
Apollo Ankle Fracture Plating System
K213005 · HRS
Glw Medical, Inc.
Orthopedic · 172d
Cleared Mar 11, 2022
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar...
K213354 · GEI
Conmed Corporation
General & Plastic Surgery · 150d