14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114087·SIMCOE CORTEX EXTRACTOR (PK/10)
NA
FDA UDI
STERILMED, INC.·10888551019859·SAW BLADE REPEAT STERNOTOMY
MICROCHOICE
FDA UDI
Conmed Corporation·10845854006160·MICROCHOICE REPEAT STERNOTOMY BLADE 65.8 MM
HOMMED OBSERVER, MODEL I
FDA 510(k)
FDA Class 2
·Cardiovascular
RAPIDONE-ECSTASY TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
UNK
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code ORG·August 25, 2023
ZIMMER ELECTRIC DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 27, 2013
PENUMBRA SYSTEM 054
FDA Adverse Event
Death
·PENUMBRA INC.·Product code NRY·February 15, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
ANGEL CENTRIFUGE US (REFURBISHED)
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code ORG·August 24, 2023
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