14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BURBANK TENACULUM, MODEL 09-0011-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TABLE,TREATMENT,SHELF,78X30
FDA UDI
Hausmann Enterprises, LLC·00840314802248·
TABLE,TREATMENT,CABINET,78X30X31
FDA UDI
Hausmann Enterprises, LLC·00840314802521·
TABLE,TREATMENT,H-BRACE,78X30
FDA UDI
Hausmann Enterprises, LLC·00840314802088·
TABLE,TREATMENT,SHLF,CAB,78X30
FDA UDI
Hausmann Enterprises, LLC·00840314802392·
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
MERIT DRAINAGE DEPOT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNK_SMART TOUCH BIDIRECTIONAL SF
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·December 19, 2022
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·April 2, 2013
SYNCHRON® CX5 DELTA CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 25, 2011
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·April 16, 2008
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013