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

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PRESEP OLIGON OXIMETRY CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00600931·

Medallion®

FDA UDI
Merit Medical Systems, Inc.·00884450029978·

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0600030·Tray Insert, Level 3

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0600130·Tray Insert 3, Cosmolock Deformity

BD BBL¿ VITAMIN K1 - HEMIN SOLUTION

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·August 6, 2024

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474

FDA 510(k)
FDA Class 2 ·Anesthesiology

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD BBL¿ VITAMIN K1 - HEMIN SOLUTION

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

S5 CONTROL DISPLAY MODULE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

S5 DOUBLE HEAD PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

S5 DOUBLE HEAD PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

S5 DOUBLE HEAD PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

S5 CONTROL DISPLAY MODULE

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

S5 CONTROL PANEL

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

S5 CONTROL DISPLAY MODULE

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

PELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·TISSUE SCIENCE LABS.·Product code FTL·April 11, 2013

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2008

2124215-2011-05924

FDA Adverse Event
Injury ·GUIDANT PUERTO RICO BV·Product code LWS·April 15, 2011

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016