14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
STARCARE HANDPIECE MAINTENANCE UNIT
FDA 510(k)
FDA Class 1
·Dental
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
FDA 510(k)
FDA Class 2
·Orthopedic
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM
FDA Adverse Event
Malfunction
·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015
CAIMAN DISP INSTR ARTICULAT D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 16, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 10, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·April 15, 2015
CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014
BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·July 3, 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