11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
3M™ Unitek™ SmartClip™ MBT™
FDA UDI
3m do Brasil Ltda.·00652221003942·SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5...
OPUS ROD FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CEMENTED CALCAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 9, 2013
ENDOTAK ENDURANCE EZ
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 7, 2011
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 13, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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