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
10873–10896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2023
LIGHTSCALPEL LS-4020
K213669 · GEX
Lightscalpel, Inc.
General & Plastic Surgery · 450d
Cleared Feb 15, 2023
Tanning Lamp
K221523 · LEJ
Unilam Co., Ltd.
General & Plastic Surgery · 265d
Cleared Feb 15, 2023
Altis Single Incision Sling System
K221874 · PAH
Coloplast A/S
Gastroenterology & Urology · 232d
Cleared Feb 15, 2023
Verisafe Safety sterile needles
K222271 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 201d
Cleared Feb 15, 2023
ZEUS System
K222389 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 191d
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Feb 15, 2023
SC HONKYTONK PTCA Balloon Dilatation Catheter
K223022 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 139d
Cleared Feb 15, 2023
Xpert® FII & FV
K223046 · NPR
Cepheid
Hematology · 139d
Cleared Feb 15, 2023
Versana Essential
K223407 · IYN
GE Medical Systems Ultrasound and...
Radiology · 98d
Cleared Feb 15, 2023
ONE DROP Lancing Device
K223815 · QRK
Stat Medical Devices
General & Plastic Surgery · 57d
Cleared Feb 15, 2023
Cobra Catheter System
K223891 · QEW
Endovascular Engineering
Cardiovascular · 50d
Cleared Feb 15, 2023
ReShape Calibration Tubes
K230131 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 29d
Cleared Feb 15, 2023
Digital Radiography CXDI-CS01
K230175 · MQB
Canon, Inc.
Radiology · 26d
Cleared Feb 14, 2023
Endocem MTA Premixed Regular
K213757 · KIF
Maruchi
Dental · 441d
Cleared Feb 14, 2023
Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device,...
K221468 · MAI
Acuitive Technologies, Inc.
Orthopedic · 270d
Cleared Feb 14, 2023
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved...
K221490 · ODP
Stryker Spine
Orthopedic · 267d
Cleared Feb 14, 2023
StitchKit
K221527 · GAM
Origami Surgical Inc .
General & Plastic Surgery · 264d
Cleared Feb 14, 2023
Creo Electrosurgical System with NP1 Instrument
K221672 · NEY
Creo Medical, Ltd.
General & Plastic Surgery · 250d
Cleared Feb 14, 2023
X-Pac Expandable LLIF Cage System
K223174 · MAX
Expanding Innovations, Inc.
Orthopedic · 126d
Cleared Feb 14, 2023
8ch T/R Knee Coil
K223225 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Feb 13, 2023
Sofjec
K212635 · FMF
Hwajin Medical Co., Ltd.
General Hospital · 543d
Cleared Feb 13, 2023
Curiteva Porous PEEK Cervical Interbody Fusion System
K213030 · ODP
Curiteva, Inc.
Orthopedic · 510d
Cleared Feb 13, 2023
Sterilization Pouch and Roll
K221875 · FRG
Qianjiang Kingphar Medical Packaging...
General Hospital · 230d
Cleared Feb 13, 2023
Bloomlife MFM-Pro
K222327 · HGM
Bloom Technologies NV
Obstetrics & Gynecology · 195d