International Medical Devices Database

Data Source

Country

Device Classification

Parent Company

Micro-sponge elastic patch for wound closure Microfoam

Model / Serial
Manufacturer
3M Brookings
1 Event
- Recall of Micro-sponge elastic patch for wound closure Microfoam

Tape indicator for quality control sterilization Comply

Model / Serial
Manufacturer
3M Company
1 Event
- Recall of Tape indicator for quality control sterilization Comply

Heat-stabilizing mattresses and blankets heating to Bair Hugger convection type systems for patie...

Model / Serial
Manufacturer
3M Company, 3M Health Care
1 Event
- Recall of Heat-stabilizing mattresses and blankets heating to Bair Hugger convection type systems for patient heating

Surgical fixatives

Model / Serial
Manufacturer
3M Company, 3M Health Care
1 Event
- Recall of Surgical fixatives

Reagents, control materials and calibrators for in vitro detection of prostate-specific antigen (...

Model / Serial
Manufacturer
Abbott Island Diagnostic Division
1 Event
- Recall of Reagents, control materials and calibrators for in vitro detection of prostate-specific antigen (PSA) on AxSYM and ARCHITECT i immunochemical analyzers

In vitro diagnostic reagents for immunochemical analyzer ARCHITECT

Model / Serial
Manufacturer
Abbott Laboratories
2 Events
- Recall of In vitro diagnostic reagents for immunochemical analyzer ARCHITECT
- Recall of In vitro diagnostic reagents for immunochemical analyzer ARCHITECT

Reagents, control materials, calibrators and reagent accessories for the assessment of the hormon...

Model / Serial
Manufacturer
Abbott Laboratories
1 Event
- Recall of Reagents, control materials, calibrators and reagent accessories for the assessment of the hormonal status on the immunochemical analyzer ARCHITECT i

In vitro reagents for CELL-DYN Emerald hematology analyzer

Reagent kit, calibrators and controls for the in vitro determination of highly sensitive troponin...

Model / Serial
Manufacturer
Abbott Laboratories
1 Event
- Recall of Reagent kit, calibrators and controls for the in vitro determination of highly sensitive troponin-I on immunochemical analyzers ARCHITECT i

In vitro diagnostic reagents and consumables for the modular immunochemical analyzer ARCHITECT i

Model / Serial
Manufacturer
Abbott Laboratories
1 Event
- Recall of In vitro diagnostic reagents and consumables for the modular immunochemical analyzer ARCHITECT i

In vitro diagnostic reagents for biochemical analyzers with ion-selective block AEROSET and ARCHI...

Model / Serial
Manufacturer
Abbott Laboratories
1 Event
- Recall of In vitro diagnostic reagents for biochemical analyzers with ion-selective block AEROSET and ARCHITECT

In vitro diagnostic reagents for the detection of active vitamin B12, testosterone and glycosylat...

Reagents, control materials and calibrators for in vitro diagnostics on immunochemical analyzers ...

Model / Serial
Manufacturer
Abbott Laboratories Corporation
1 Event
- Recall of Reagents, control materials and calibrators for in vitro diagnostics on immunochemical analyzers ARCHITECT i

In vitro diagnostic reagents for biochemical analyzers with the ion-selective block AEROSET and A...

Model / Serial
Manufacturer
Abbott Laboratories, USA
1 Event
- Recall of In vitro diagnostic reagents for biochemical analyzers with the ion-selective block AEROSET and ARCHITECT (see the appendix on 3 sheets)

Devices for intravascular manipulations and angioplasty

Model / Serial
Manufacturer
Abbott Vascular
2 Events
- Recall of Devices for intravascular manipulations and angioplasty
- Recall of Devices for intravascular manipulations and angioplasty

Stent peripheral nitinol self-expanding SUPERA with delivery system

Model / Serial
Manufacturer
Abbott Vascular
1 Event
- Recall of Stent peripheral nitinol self-expanding SUPERA with delivery system

Balloon catheter TREK / MINI TREK

Model / Serial
Product Classification
Cardiovascular Devices
Manufacturer
Abbott Vasculaur
1 Event
- Recall of Balloon catheter TREK / MINI TREK

StarClose SE Vascular Closure System extravascular vascular access tool

Model / Serial
Manufacturer
Abbott Vasculaur
1 Event
- Recall of StarClose SE Vascular Closure System extravascular vascular access tool

Brio pulse generator implantable to stimulate the brain with accessories

Model / Serial
Manufacturer
St. Jude Medical
1 Event
- Recall of Brio pulse generator implantable to stimulate the brain with accessories

Impulse generator implantable in versions of Infinity 5 (models 6660, 6661), Infinity 7 (models 6...

Model / Serial
Manufacturer
St. Jude Medical
1 Event
- Recall of Impulse generator implantable in versions of Infinity 5 (models 6660, 6661), Infinity 7 (models 6662, 6663) with accessories

The SD BIOLINE reagent kit for the rapid in vitro determination of HIV infection

Model / Serial
Manufacturer
Standard Diagnostics, Inc.
1 Event
- Recall of The SD BIOLINE reagent kit for the rapid in vitro determination of HIV infection

Surgical suture material with atraumatic needles and without needles

Model / Serial
Manufacturer
Resorba Medical GmbH
2 Events
- Recall of Surgical suture material with atraumatic needles and without needles
- Recall of Surgical suture material with atraumatic needles and without needles

Medical X-ray film CEA RP new, CEA OGA

Model / Serial
Manufacturer
Agfa Helskea N.V., Belgium
1 Event
- Recall of Medical X-ray film CEA RP new, CEA OGA

Medical gauze cuts according to GOST 16427-93 are non-sterile in the following sizes: 1000 cm x 9...

Model / Serial
Manufacturer
PKF Akhtamar LLC
1 Event
- Recall of Medical gauze cuts according to GOST 16427-93 are non-sterile in the following sizes: 1000 cm x 90 cm and 1000 cm x 84 cm.

Medical gauze sterile and non-sterile wipes according to GOST 16427-93

Model / Serial
Manufacturer
PKF Akhtamar LLC
1 Event
- Recall of Medical gauze sterile and non-sterile wipes according to GOST 16427-93

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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