103 results
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72ms
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Sources: EU EUDAMED, US FDA
SHAPE MEDICAL SYSTEMS, INC
FDA registration
SHAPE MEDICAL SYSTEMS, INC·1 product·🇺🇸 United States
Shape-HF
FDA UDI
Shape Medical Systems, Inc.·B20089001·Shape-HF system
Shape-HF
FDA UDI
Shape Medical Systems, Inc.·B20044001·Disposable Patient Interface is part of the Sha...
Shape
FDA UDI
Shape Medical Systems, Inc.·B200HF012·Paramagnetic Shape analyzer Product 0012
Shape Vital Sign System
FDA UDI
Shape Medical Systems, Inc.·B20083012·Full Shape II system with paramagnetic analyzer
Shape
FDA UDI
Shape Medical Systems, Inc.·B20040011·Shape DPI
Disposable Patient Interface with filter
FDA UDI
Shape Medical Systems, Inc.·B20044012·Disposable patient interface with filter 0004-4012
Shape II System Refurbished
FDA UDI
Shape Medical Systems, Inc.·B2009012·Full Shape II system with paramagnetic analyzer
Shape-HF
FDA UDI
Shape Medical Systems, Inc.·B200HF001·Shape-HF analyzer
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
FDA Recall
Terminated
·Shape Medical Systems, Inc·Product code BTY·December 23, 2014
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
FDA Recall
Terminated
·Shape Medical Systems, Inc·Product code BTY·May 28, 2014
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
FDA Enforcement
Class II
·Terminated·Shape Medical Systems, Inc·July 23, 2014
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
FDA Enforcement
Class II
·Terminated·Shape Medical Systems, Inc·February 11, 2015
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B. BRAUN MELSUNGEN AG·Product code DYB·March 27, 2019
12X150MM KII SHIELDED BLADED ACCESS SYS THREADED
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·July 8, 2011
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013
GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 14, 2025
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·November 20, 2013
MedR-AR Services B.V.
Authorized representative
🇳🇱 Netherlands·13 Manufacturers·31 Devices