27 results · 28ms · Sources: EU EUDAMED, US FDA

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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