11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
INSTANT-VIEW Pregnancy Combo Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000030·INSTANT-VIEW HCG Combo Cassette Test
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
PYXIS MEDSTATION ES SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION 303·Product code BRY·March 7, 2025
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 19, 2017
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·March 20, 2013
SM104 MSERIES W/5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 15, 2011
LUPINE DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·March 31, 2008
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