22 results
·
36ms
·
Sources: EU EUDAMED, US FDA
IL TEST PROS
FDA 510(k)
FDA Class 2
·Hematology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040015148·Zirlux 16+ White 65x25x22
MaXcess
FDA UDI
Nuvasive, Inc.·00887517065889·MaXcess Decomp Pituitary, 4mm Str
OneTouch Ultra Blue
FDA UDI
LifeScan Europe GmbH·00353885011563·OneTouch Ultra Test Strips Blue for blood gluco...
OneTouch Ultra Blue
FDA UDI
LifeScan Europe GmbH·00353885011570·OneTouch Ultra Test Strips Blue for blood gluco...
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033277072·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033277058·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033277089·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033277065·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 15, 2024
NEXAN SYSTEM, MODEL NX-301
FDA 510(k)
FDA Class 2
·Cardiovascular
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
FDA 510(k)
FDA Class 2
·General Hospital
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 17, 2011
PLUM A+ - ANIMAL HEA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 19, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 14, 2014
UNKNOWN DEPUY 38MM PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·March 4, 2011
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