FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24289–24312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2018
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 82d
Cleared Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904 · LJS
Piper Access, LLC
General Hospital · 71d
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Alphatec Spine, Inc.
Orthopedic · 62d
Cleared Sep 25, 2018
IBM iConnect Access
K182290 · LLZ
Merge Healthcare Incorporated
Radiology · 33d
Cleared Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 28d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 24, 2018
iNtuition-T1 Mapping and T2/T2* Mapping
K180916 · LLZ
Terarecon,Inc.
Radiology · 168d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Sep 24, 2018
Comprehensive Reverse Shoulder System
K181611 · PHX
Biomet Manufacturing Corp
Orthopedic · 97d
Cleared Sep 24, 2018
AMADEO M-DR mini, AMADEO M-AX mini
K182317 · IZL
Oehm Und Rehbein GmbH
Radiology · 28d
Cleared Sep 21, 2018
SOLOASSIST II
K171947 · NAY
Aktormed GmbH
General & Plastic Surgery · 449d
Cleared Sep 21, 2018
OpenSight
K172418 · LLZ
Novarad Corporation
Radiology · 407d
Cleared Sep 21, 2018
DePuy Corail AMT Hip Prosthesis
K173960 · LZO
Depuy France S.A.S.
Orthopedic · 267d
Cleared Sep 21, 2018
Malecot Nephrostomy Catheter/Stent Set
K180029 · FAD
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 246d
Cleared Sep 21, 2018
Cellulize
K180338 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 226d
Cleared Sep 21, 2018
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K180489 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 210d
Cleared Sep 21, 2018
BB-613 Watch Oximeter
K181006 · DQA
Bio-Beat Technologies , Ltd.
Anesthesiology · 158d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034 · HEX
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared Sep 21, 2018
AEROmini Tracheobronchial Stent System
K181200 · JCT
Merit Medical Systems, Inc.
Anesthesiology · 137d
Cleared Sep 21, 2018
PSM 3-Way Silicone Foley Catheter
K181616 · EZL
Pathway, LLC
Gastroenterology & Urology · 94d
Cleared Sep 21, 2018
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
K181665 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Sep 21, 2018
Tranquil-L Interbody System
K181702 · MAX
Nexus Spine, LLC
Orthopedic · 86d
Cleared Sep 21, 2018
Arthrex FiberTak Suture Anchor
K181769 · MBI
Arthrex, Inc.
Orthopedic · 80d