Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

85 results for "Biotronik, Inc."
1–24 of 85
Search insights Median review: 77d Cleared: 93% Top manufacturer: Biotronik, Inc. Lead specialty: Cardiovascular
Cleared May 01, 2026
BIOMONITOR IV (471155)
K261074 · MXD
Biotronik, Inc.
Cardiovascular · 30d
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 CT 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