29 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHAPE TO FIT COMPRESSION WEAR
FDA 510(k)
FDA Class 2
·General Hospital
Damon Copper Ni-Ti
FDA UDI
ORMCO CORPORATION·00889989027655·DAMON CUNITI W/STOPS 16x25 PK10
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820127·Spark™ TruColor™ headlight system - China, Type...
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00850038691011·
BACK-UP MEIER GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECSYS INSULIN CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 8, 2025
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013
RUBY COIL DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·September 19, 2014
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·May 12, 2011
GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·September 11, 2025
CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40SHA
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012