21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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29G AND 30G K-PACK II NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062608·CURVY 70 SHEER, SIZE M-XL, VISONE, GRADUATED CO...
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INVAC
FDA 510(k)
FDA Class 2
·Radiology
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/ COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 19, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 12, 2011
CURLIN INFUSION 6000 PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·March 18, 2013
HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR LLC·Product code MAL·June 18, 2008
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·April 8, 2011
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·October 30, 2013
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015