11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IDI IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Mictec Crile Wood Needle Holder
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111301·Mictec Crile Wood Needle Holder With Ratchet Tu...
ZAVATION
FDA UDI
Zavation LLC·00842166186651·8mm X 18mm 6° Trial
REFRACTIVE SURGERY BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025
PULSE GEN MODEL UNKNOWN
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·April 29, 2013
DEPUY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 3, 2011
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·July 23, 2008
VariSource AL 13197000, Tongue/Soft Tissue Kit
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code JAQ·February 21, 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