Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

84 results for "Biotronik, Inc."
1–24 of 84
Cleared Apr 04, 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
K250706 · LIT
Biotronik, Inc.
Cardiovascular · 25d
Cleared Oct 25, 2024
Pantera Pro
K242969 · LOX
Biotronik, Inc.
Cardiovascular · 29d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787 · DQY
Biotronik, Inc.
Cardiovascular · 174d
Cleared Jul 11, 2024
Oscar Peripheral Multifunctional Catheter system
K241711 · LIT
Biotronik, Inc.
Cardiovascular · 27d
Cleared May 19, 2023
BIOMONITOR IV
K230375 · MXD
Biotronik, Inc.
Cardiovascular · 95d
Cleared Feb 16, 2023
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · LIT
Biotronik, Inc.
Cardiovascular · 218d
Cleared Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037 · DQY
Biotronik, Inc.
Cardiovascular · 8d
Cleared Jul 06, 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · LIT
Biotronik, Inc.
Cardiovascular · 195d
Cleared Sep 02, 2021
MultiCath, AcQRate Dx Fixed Curve Catheter
K201445 · DRF
Biotronik, Inc.
Cardiovascular · 458d
Cleared Dec 08, 2020
Biomonitor III, Biomonitor IIIm
K201865 · MXD
Biotronik, Inc.
Cardiovascular · 155d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474 · DQY
Biotronik, Inc.
Cardiovascular · 305d
Cleared Apr 23, 2020
Biomonitor III, Biomonitor IIIm
K200444 · MXD
Biotronik, Inc.
Cardiovascular · 59d
Cleared Nov 21, 2019
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996 · DQY
Biotronik, Inc.
Cardiovascular · 24d
Cleared Aug 01, 2019
Biotronik Stylets
K191469 · DRB
Biotronik, Inc.
Cardiovascular · 59d
Cleared Jul 05, 2019
BIOMONITOR III, Remote Assistant III
K190548 · MXD
Biotronik, Inc.
Cardiovascular · 122d
Cleared Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
K183265 · DQY
Biotronik, Inc.
Cardiovascular · 20d
Cleared Jun 29, 2017
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · MXD
Biotronik, Inc.
Cardiovascular · 36d
Cleared Mar 31, 2017
BioMonitor 2-AF, BioMonitor 2-S
K170628 · MXD
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jan 26, 2017
Pantera LEO
K163660 · LOX
Biotronik, Inc.
Cardiovascular · 30d
Cleared Oct 07, 2016
Pantera Pro
K160985 · LOX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Apr 11, 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · MXD
Biotronik, Inc.
Cardiovascular · 181d
Cleared Oct 08, 2015
Passeo-14 Peripheral Dilatation Catheter
K152240 · LIT
Biotronik, Inc.
Cardiovascular · 59d
Cleared Oct 08, 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · LIT
Biotronik, Inc.
Cardiovascular · 101d