15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MB 105 MILLENNIUM BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
Audit MicroControls Control FD Assayed Chemistry, Level 1
FDA UDI
AALTO SCIENTIFIC·B085K0311100·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522466·Cannulated Canc Screw,36mm Thd,7.0x110mm
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 110mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010084·
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
SwingLine
FDA UDI
Ropox A/S·05707581000034·
CRYSTAL-EEG MODEL 15
FDA 510(k)
FDA Class 2
·Neurology
M2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
HATCP STEM POR TIB PLT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 5, 2024
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013
UNKNOWN ZIMMER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWY·March 29, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
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