33 results · 23ms · Sources: EU EUDAMED, US FDA

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MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS

FDA 510(k)
FDA Class 2 ·Dental

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014606460·MIDMARK CHIC CST 3.25 SOFTCARE PLUS

Conformis Hip System

FDA UDI
Conformis, Inc.·00810933030070·REAMER, ACETABULAR, 52MM FULL

SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

5F GUIDING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017

OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017

CARDIAC SURGERY PACK BO-TOP 36500

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017

CUSTOM TUBING PACK

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

CUSTOM TUBING PACKS

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

ENDURANT BIFURCATED STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 22, 2011

ACCU-CHEK COMFORT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

BO-TOP 36500 QUADROX OXYGENATOR

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017

CUSTOM TUBING PACK

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·September 28, 2017

Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

FDA Enforcement
Class III ·Terminated·Spinal Elements, Inc·May 15, 2013

BEQ-TOP 5210 ECC PACK

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·November 9, 2017

CUSTOM PACK BO-T 25102

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017

CUSTOM TUBING PACK BO TOP 25102

FDA Adverse Event
Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017