27 results
·
28ms
·
Sources: EU EUDAMED, US FDA
TOMOPHASE OCTIS
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
FDA 510(k)
FDA Unclassified
·Unknown
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
FDA 510(k)
FDA Class 2
·Neurology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970102·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970089·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970119·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970096·
GALAXY G3 MINI 1MM X 1CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 1, 2013
STREAMLINE MIS PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·PIONEER SURGICAL·Product code NKB·August 28, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·May 20, 2011
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
UNKNOWN NEXGEN FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 8, 2022
UNKNOWN FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 8, 2022
UNKNOWN ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 8, 2022
UNKNOWN NEXGEN LPS-FLEX PS TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 8, 2022
UNKNOWN NEXGEN LPS-FLEX PS TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 8, 2022
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