17 results · 22ms · Sources: EU EUDAMED, US FDA

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IPS E.MAX CAD/IPS E.MAX ZIRCAD

FDA 510(k)
FDA Class 2 ·Dental

Matira

FDA UDI
Kalitec Direct LLC·B07307K0157050·Trial Drill Guide Tube, 5mm

SUPREMCAST

FDA 510(k)
FDA Class 2 ·Dental

STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

FDA 510(k)
FDA Class 2 ·Neurology

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·January 7, 2025

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·March 28, 2025

PEN NDL 32G 4MM PRO 100 BOX 1200 CA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·March 27, 2025

RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

FDA Adverse Event
Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

BLAKE DRAIN

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GCY·May 21, 2008

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-125.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

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