FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16849–16872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2021
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced...
K211465 · DQK
Edwards Lfesciences
Cardiovascular · 58d
Cleared Jul 08, 2021
NubeX
K211480 · LLZ
Techheim Co., Ltd.
Radiology · 57d
Cleared Jul 08, 2021
HALO
K211788 · QAS
Nicolab B.V.
Radiology · 29d
Cleared Jul 07, 2021
Arterial Catheter
K201726 · DQY
Haolang Medical USA Corporation
Cardiovascular · 379d
Cleared Jul 07, 2021
Hydrozid
K201740 · GEH
Medilink A/S
General & Plastic Surgery · 377d
Cleared Jul 07, 2021
Infrared Forehead Thermometer
K202741 · FLL
Shenzhen Combei Technology Co., Ltd.
General Hospital · 292d
Cleared Jul 07, 2021
Pantheon IBFD
K203003 · MAX
Pantheon Spinal
Orthopedic · 279d
Cleared Jul 07, 2021
Axium Detachable Coil
K203432 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 226d
Cleared Jul 07, 2021
Surgical Gowns
K210215 · FYA
Jiangsu Province Jianerkang Medical...
General Hospital · 161d
Cleared Jul 07, 2021
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo,...
K210497 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 135d
Cleared Jul 07, 2021
Surgical Mask
K210524 · FXX
Changzhou Holymed Products Co., Ltd.
General Hospital · 134d
Cleared Jul 07, 2021
ONE Planner Hip
K210653 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 125d
Cleared Jul 07, 2021
Grappler Suture Anchor System
K211002 · MBI
Paragon 28, Inc.
Orthopedic · 96d
Cleared Jul 07, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K211818 · LNH
Hyperfine, Inc.
Radiology · 26d
Cleared Jul 06, 2021
TRIOCLEAR System
K193622 · NXC
Perfection Aligner System Hong Kong...
Dental · 558d
Cleared Jul 06, 2021
KARL STORZ Metal Sterilization Trays
K203198 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 250d
Cleared Jul 06, 2021
NUVO CF Implant System
K203309 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 238d
Cleared Jul 06, 2021
SafeCross Transseptal Puncture and Introducer (TSP/I) System
K203459 · DYB
East End Medical I, LLC
Cardiovascular · 224d
Cleared CT Jul 06, 2021
AcuPebble SA
K210480 · MNR
Acurable Limited
Anesthesiology · 137d
Cleared Jul 06, 2021
DEKA Motus AZ
K211821 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 25d
Cleared Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 515d
Cleared Jul 02, 2021
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
K202241 · MRX
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 326d
Cleared Jul 02, 2021
Insulin Syringe, Insulin Syringe with Safety Retractable
K202570 · MEG
Jiangsu Micsafe Medical Technology...
General Hospital · 301d
Cleared Jul 02, 2021
Disposable Surgical Mask
K202954 · FXX
Xiamen Probtain Medical Techology...
General Hospital · 275d