69 results · 21ms · Sources: EU EUDAMED, US FDA

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MAGEC® System

FDA 510(k)
FDA Class 2 ·Orthopedic

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018753·Inflow Cannula Small 3mm Diameter

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

FDA 510(k)
FDA Class 2 ·Neurology

ROSA SURGICAL DEVICE

FDA 510(k)
FDA Class 2 ·Neurology

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·August 1, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 14, 2018

Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

FDA Enforcement
Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017