19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
1.0MM STERNAL CABLE-LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDQ·August 27, 2010
MALLEABLE SHAFT CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code GEX·March 28, 2013
CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FCL·March 16, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 17, 2014
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018