13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VENUS FLOW
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033665·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, THC
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001143·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...
FADASSI MEDICAL FM-1 NO BLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDO SMARTCAP
FDA Adverse Event
MEDIVATORS·Product code KOG·February 2, 2015
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·April 3, 2013
4.5MM CANNULATED SCREW PARTIALLY THREADED/56MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·March 23, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024