15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033054·Baltic Denture System BDLoad Ln6 PLSEbil2DFl D2...
INSTANT-VIEW Cocaine (150) Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000412·INSTANT-VIEW Cocaine (150) Urine Cassette Test
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
AUTOSTAT II ENA-6 PROFILE ELISA
FDA 510(k)
FDA Class 2
·Immunology
KONICA DIRECT DIGITIZER REGIUS MODEL 350
FDA 510(k)
FDA Class 2
·Radiology
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
ECHO POR FMRL LAT NC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 6, 2020
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 30, 2011
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·April 23, 2008
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024