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
11953–11976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2022
Fiber Laser Treatment System
K221770 · ONG
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 114d
Cleared Oct 13, 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer,...
K221857 · DXQ
Zhejiang Lude Technology Development...
Cardiovascular · 108d
Cleared Oct 13, 2022
The Oligio
K221989 · GEI
Wontech Co., Ltd.
General & Plastic Surgery · 99d
Cleared Oct 13, 2022
ID-510 iRestore Elite
K222081 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 90d
Cleared Oct 13, 2022
SCIg60 Infusion System
K222087 · PKP
Emed Technologies Corporation
General Hospital · 90d
Cleared Oct 13, 2022
Abiomed 14Fr Low Profile Introducer Set
K222113 · DYB
Abiomed, Inc.
Cardiovascular · 87d
Cleared Oct 13, 2022
UNITY Sacroiliac Joint Fixation System
K222448 · OUR
Dio Medical Corporation
Orthopedic · 59d
Cleared Oct 13, 2022
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
K222473 · NKB
Medos International SARL
Orthopedic · 58d
Cleared Oct 13, 2022
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
K222763 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 30d
Cleared Oct 12, 2022
AT-Patch ECG Analysis System
K203638 · DSH
Atsens Co., Ltd.
Cardiovascular · 667d
Cleared Oct 12, 2022
PiezoImplant System
K211872 · NRQ
Rex Implants, Inc.
Dental · 482d
Cleared Oct 12, 2022
OW100S (model OW100S-US)
K213120 · ISA
Tissue Regeneration Technologies, LLC...
Physical Medicine · 380d
Cleared Oct 12, 2022
MOST-T Autoclave
K220102 · FLE
Shinva Medical Instrument Co., Ltd.
General Hospital · 273d
Cleared Oct 12, 2022
Auto Folding Scooter, S21F
K220227 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 258d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · LFZ
Roche Diagnostics
Microbiology · 197d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · MXJ
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · MYF
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · LPN
Chemtex USA, Inc.
Ophthalmic · 163d
Cleared Oct 12, 2022
TrusFIL-Flow Flowable Composite Restorative
K221510 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 141d
Cleared Oct 12, 2022
Ameda Pearl Electric Breast Pump
K221576 · HGX
Ameda, Inc.
Obstetrics & Gynecology · 133d
Cleared Oct 12, 2022
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
K221712 · GEX
Fotona D.O.O.
General & Plastic Surgery · 121d
Cleared Oct 12, 2022
Arm Blood Pressure Monitor
K221913 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 104d
Cleared Oct 12, 2022
The Alma Soprano Titanium
K222064 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Oct 12, 2022
Durex Penck III Regular
K222068 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d