16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOSS MIAMI SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478226·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478219·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478196·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478233·
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·BIOFORM MEDICAL, INC.·Product code LMH·May 19, 2009
BIOMET SCK KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2014
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES, INC·Product code LWR·March 12, 2008
CLS STEM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURIN GMBH·Product code KWY·November 25, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025