13 results
·
24ms
·
Sources: EU EUDAMED, US FDA
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033940·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
LASER SYSTEM YELLOWSTAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2010 PLUS HOLTER FOR WINDOWS
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A MAGNUM MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 24, 2017
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 3, 2013
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·March 18, 2011
DXTEND SCREW LOCK D4.5X42MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code HSD·April 24, 2008
CORAIL AMT COLLAR SIZE 8
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWA·September 16, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018