20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PKS OMNI INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 14, 2011
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013
SUMMIT CEMENTED STEM SZ6 STD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013
PINN CAN BONE SCREW 6.5MMX30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HWC·December 4, 2013
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 4, 2013
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·December 4, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 4, 2013
SMARTSET GMV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LOD·December 4, 2013
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HWC·December 4, 2013
CEMENTRALIZER 12.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013
SMARTSET GMV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LOD·December 4, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 13, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2008
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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