20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COCAINE DIPSTICK TEST, MODEL D747-A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07901089813082·H49-TRAY F/INST.STANDER---BEIGE
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117491·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117569·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117507·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117613·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117118·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033117484·
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
FDA 510(k)
FDA Class 2
·Hematology
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016
SMALL BATTERY DRIVE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWE·March 19, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
MALLINCKRODT
FDA Adverse Event
Injury
·TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIVISION·Product code BTR·March 7, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·H10·Product code KWP·April 4, 2013
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014