16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
Mini-SG® F/R / Mini-SG®
FDA UDI
Cendres+Métaux SA·07640173091776·Mini-SG® F/R / Mini-SG®
Insert remover
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108697·MIYAKE LACRIMAL PROBE .55 AND .6MM
POWER 5000 GENERAL PURPOSE COIL
FDA 510(k)
FDA Class 2
·Radiology
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FASTI INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
INSYNC ICD
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·July 10, 2008
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 29, 2011
BD¿ SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 23, 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
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