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
6241–6264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2024
MyoStrain (6.0)
K241607 · LNH
Myocardial Solutions, Inc.
Radiology · 83d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538 · DQY
Abbott Medical
Cardiovascular · 88d
Cleared Aug 26, 2024
DESS Dental Smart Solutions
K240982 · NHA
Terrats Medical SL
Dental · 138d
Cleared Aug 26, 2024
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · FXX
Primed Medical Products, Inc.
General Hospital · 207d
Cleared Aug 23, 2024
TMINI Miniature Robotic System
K242264 · OLO
THINK Surgical, Inc.
Orthopedic · 22d
Cleared Aug 23, 2024
LightWalker Laser System Family
K242202 · GEX
Fotona D.O.O.
General & Plastic Surgery · 28d
Cleared Aug 23, 2024
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K242191 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 29d
Cleared Aug 23, 2024
Morph DNA Steerable Introducer Sheath
K242169 · DYB
Biocardia
Cardiovascular · 30d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780 · LZA
Cardinal Health200, LLC
General Hospital · 64d
Cleared Aug 23, 2024
Guided Surgery Kit Cases
K241492 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 87d
Cleared Aug 23, 2024
SonoSync
K241302 · LLZ
Samsung Medison Co., Ltd.
Radiology · 106d
Cleared Aug 23, 2024
ONE Nitrile Condom
K240896 · MOL
Global Protection Corp.
Obstetrics & Gynecology · 144d
Cleared Aug 23, 2024
Polyisoprene Surgical gloves
K240790 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 154d
Cleared Aug 23, 2024
VEEGix EEG System
K240593 · OLT
Neuroservo, Inc.
Neurology · 175d
Cleared Aug 23, 2024
SITTER 3.5mm Versatile System
K240318 · HRS
Bonebridge AG
Orthopedic · 203d
Cleared Aug 23, 2024
Nova Micro Pillows Mask Small A Model (NVP1SA)
K233829 · BZD
Fisher and Paykel Healthcare Limited
Anesthesiology · 266d
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · GZB
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
K233358 · QVF
InBios International, Inc.
Microbiology · 329d
Cleared Aug 23, 2024
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap,...
K231100 · DZE
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 493d
Cleared Aug 22, 2024
Introducer Sheath Kits
K242248 · DYB
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 22d
Cleared Aug 22, 2024
I.V. Administration Set
K242126 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 34d
Cleared Aug 22, 2024
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
K241979 · IYN
Beijing Konted Medical Technology...
Radiology · 48d
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804 · JDS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 22, 2024
INSULCLOCK® v2.0 PRO
K241803 · QOG
Insulcloud S.L.
General Hospital · 62d