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
11497–11520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · MQB
Careray Digital Medical Technology...
Radiology · 21d
Cleared Dec 29, 2022
EndoPATx
K211557 · DQK
Itamar Medical , Ltd.
Cardiovascular · 589d
Cleared Dec 29, 2022
Multi-Parameter Patient Monitor
K211619 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 582d
Cleared Dec 29, 2022
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical...
K220935 · FKX
Iren-Medical, Ltd.
Gastroenterology & Urology · 273d
Cleared Dec 29, 2022
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K221333 · HWC
Acumed, LLC
Orthopedic · 234d
Cleared Dec 29, 2022
AG100s
K221477 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 220d
Cleared Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE...
K221690 · FAJ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 202d
Cleared Dec 29, 2022
Atalante
K221859 · PHL
Wandercraft SAS
Neurology · 185d
Cleared Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981 · MEG
Roncadelle Operations Srl
General Hospital · 177d
Cleared Dec 29, 2022
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life...
K222528 · KPI
Well-Life Healthcare Limited
Gastroenterology & Urology · 129d
Cleared Dec 29, 2022
BioClean Implant Restorative System
K222984 · NHA
Bioclean Dental, LLC
Dental · 92d
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
Cleared Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K223592 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Dec 29, 2022
Reflow System Mini and ReFlow Mini Flusher
K223603 · JXG
Anuncia Medical, Inc.
Neurology · 27d
Cleared Dec 29, 2022
CLEAR+BRILLIANT TOUCH® Laser System
K223647 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 23d
Cleared Dec 28, 2022
nView s1 with nav option
K221344 · OWB
Nview Medical
Radiology · 233d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Dec 28, 2022
StageOne™ Select Hip Cement Spacer Molds
K222760 · MBB
Biomet, Inc.
Orthopedic · 106d
Cleared Dec 28, 2022
BD AutoShield Duo™ Pen Needle
K223286 · FMI
Becton, Dickinson and Company
General Hospital · 64d
Cleared Dec 28, 2022
Medussa-PL Cage
K223654 · MAX
Medyssey USA, Inc.
Orthopedic · 22d
Cleared Dec 27, 2022
R:GEN
K220974 · HQF
Lutronic Vision, Inc.
Ophthalmic · 267d
Cleared Dec 27, 2022
IOB Warming Blankets
K221669 · DWJ
Iob Medical, Inc.
Cardiovascular · 201d
Cleared Dec 27, 2022
Access Total ßhCG (5th IS)
K221990 · DHA
Beckman Coulter, Inc.
Chemistry · 174d
Cleared Dec 27, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K222978 · QUW
Xiros, Ltd.
Orthopedic · 90d