15 results
·
71ms
·
Sources: EU EUDAMED, US FDA
Ambulatory Monitoring, Inc.
Manufacturer
🇺🇸 United States
AMBULATORY MONITORING, INC.
FDA registration
AMBULATORY MONITORING, INC.·3 products·🇺🇸 United States
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·February 20, 2013
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·November 28, 2012
UNK - SCREWS: TOMOFIX
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·September 30, 2021
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·September 30, 2010
UNK - CONSTRUCTS: SMALL FRAGMENT LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 19, 2021
UNK - ELASTIC NAILS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·April 19, 2021
UNK - ELASTIC NAILS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·April 19, 2021
UNK - ELASTIC NAILS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·April 19, 2021
UNK - CONSTRUCTS: SMALL FRAGMENT LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 19, 2021
UNK - ELASTIC NAILS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·April 19, 2021
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code FKX·December 27, 2010
UNK - CONSTRUCTS: SMALL FRAGMENT LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 19, 2021
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices