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

52 results for "CardioMed Device Consultants, LLC"
1–24 of 52
Search insights Median review: 121d Cleared: 100% Top manufacturer: Asahi Intecc Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 04, 2025
MitraPatch Mitral Valve Repair System
K252126 · PAW
Chawla Heart Technologies, LLC
Cardiovascular · 150d
Cleared Jun 27, 2024
Faros Surgical System
K233398 · HQC
Oertli Instrumente AG
Ophthalmic · 268d
Cleared May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
K231169 · MLR
Plasmapp Co,., Ltd.
General Hospital · 30d
Cleared May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
K223023 · FRC
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared Feb 15, 2023
SC HONKYTONK PTCA Balloon Dilatation Catheter
K223022 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 139d
Cleared Dec 21, 2022
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
K222538 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 121d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631 · DQX
Filmecc Co., Ltd.
Cardiovascular · 56d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949 · DQX
Filmecc Co., Ltd.
Cardiovascular · 195d
Cleared Oct 22, 2021
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · MLR
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · FRG
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators...
K212193 · FRC
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Jul 09, 2021
Tamarin Blue PTCA RX Dilatation Catheter
K210012 · LOX
Natec Medical , Ltd.
Cardiovascular · 186d
Cleared May 21, 2021
Neurescue device
K210358 · MJN
Neurescue Aps
Cardiovascular · 102d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529 · DQX
Filmecc Co., Ltd.
Cardiovascular · 153d
Cleared Apr 21, 2021
VASSALLO GT
K203533 · DQX
Filmecc Co., Ltd.
Cardiovascular · 140d
Cleared Apr 28, 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867 · DZE
Novodent SA
Dental · 27d
Cleared Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K200254 · HKI
Optina Diagnostics
Ophthalmic · 84d
Cleared Aug 01, 2019
MINAMO
K190176 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 181d
Cleared Jul 01, 2019
ASAHI Silverway
K183062 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Jun 22, 2019
ASAHI SASUKE
K182844 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 256d
Cleared Apr 29, 2019
Aspiron(TM) Aspiration Catheter
K190619 · QEZ
Meril Life Sciences Private Limited
Cardiovascular · 49d
Cleared Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070 · MOF
Asahi Intecc Co., Ltd.
Neurology · 85d
Cleared Dec 20, 2018
ASAHI Corsair Pro XS
K182420 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 106d
Cleared Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
K181266 · DZE
Novodent SA
Dental · 171d