52 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
FDA 510(k)
FDA Class 2
·Cardiovascular
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583033372·ENCHANT 80 B 105 FW 3.0
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181897·Integra® Jarit® Meyerding Finger Retractor, 7",...
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
FDA 510(k)
FDA Class 2
·Cardiovascular
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·December 8, 2003
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 29, 2002
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
HIRES 90K IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·October 17, 2014
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS INC.·Product code LMH·June 17, 2013
OSTEOFIL DBM PASTE
FDA Adverse Event
Injury
·REGENERATION TECHNOLOGIES, INC.·Product code MQV·February 27, 2007
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2018
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 11, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·July 17, 2023
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·May 28, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·June 21, 2024
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·January 15, 2025