DTE

Product Code: DTE


Products Classified as DTE

783Pulse-generator, Pacemaker, ExternalExternal Pacemaker Pulse Generator.

Total Product Life Cycle (TPLC) Devices

783Pulse-generator, Pacemaker, ExternalExternal Pacemaker Pulse Generator.

FDA Consensus Standards

Pulse-Generator, Pacemaker, External [36797]21 CFR §870.3600 🔎
Pulse-Generator, Pacemaker, External [30295]21 CFR §870.3600 🔎

Pre-market Notifications for DTE

K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.
K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.
K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.
K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.
K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc.
K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.
K162054Medtronic Temporary External Pacemaker 53401MEDTRONIC, INC.
K150246Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc
K132924MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)MEDTRONIC, INC.
K123916PSA SERIESOSYPKA MEDICAL, INC.
K042708ERA 3000 PACING SYSTEM ANALYZERBIOTRONIK, INC.
K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROSYPKA MEDICAL, INC.
K023080GALIX PACESTARGALIX BIOMEDICAL INSTRUMENTATION, INC.
K022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIESOSYPKA MEDICAL, INC.
K020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENEOSYPKA MEDICAL, INC.

Global Unique Device Identification Database

00643169725126PULSE-GENERATOR, PACEMAKER, EXTERNAL
00643169723160PULSE-GENERATOR, PACEMAKER, EXTERNAL
00643169508767PULSE-GENERATOR, PACEMAKER, EXTERNAL
00643169382978PULSE-GENERATOR, PACEMAKER, EXTERNAL
00643169305120PULSE-GENERATOR, PACEMAKER, EXTERNAL
00643169230859PULSE-GENERATOR, PACEMAKER, EXTERNAL
00763000162443PULSE-GENERATOR, PACEMAKER, EXTERNAL
00885672005467PULSE-GENERATOR, PACEMAKER, EXTERNAL
00847946021986PULSE-GENERATOR, PACEMAKER, EXTERNAL
00847946021191PULSE-GENERATOR, PACEMAKER, EXTERNAL
00847946016661PULSE-GENERATOR, PACEMAKER, EXTERNAL
00847946016463PULSE-GENERATOR, PACEMAKER, EXTERNAL
00847946016401PULSE-GENERATOR, PACEMAKER, EXTERNAL
04260451441029Pulse-Generator, Pacemaker, External
04260451441012Pulse-Generator, Pacemaker, External

Maude Adverse Events

DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-31
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODELMEDTRONIC, INC.2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-30
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-29
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-27
EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODELMEDTRONIC, INC.2020-03-27
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-27
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-27
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
TEMPORARY EXTERNAL PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-26
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
TEMPORARY EXTERNAL PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-25
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-24
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-24
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-24
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-23
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-23
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-23
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-23
DUAL CHAMBER TEMPORARY PACEMAKERPLEXUS MANUFACTURING SDN. BHD2020-03-23
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.