20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO:APEX MEDICAL IF-4100
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743601·LEVAMED ANKLE SUPPORT SAND III
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036011161·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130130·Sagittal Bender, Left
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521120·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521168·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521144·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521137·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521151·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134130·Trial, TLIF, 27L OB STR 7Deg, 13mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm
SIMPLICT
FDA 510(k)
FDA Class 2
·Radiology
AMEDITECH IMMUTEST DRUG SCREEN THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Phonak
FDA UDI
Phonak AG·07613275086247·Phonak Naída Q90-UP (pure transparent)
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036131753·
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00888233005296·
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·March 20, 2013
PERFORMA BERENSTEIN CATHETER
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 4, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2008
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