12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016661·STR, 10 electrode, MPD-CS-S, 2-5-2-5-2-5-2-5-2m...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111217470·PEDERSON SPEC SM W/GOLD SCREWS
CHEMO-AIDE DISPENSING PIN
FDA 510(k)
FDA Class 2
·General Hospital
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
FDA 510(k)
FDA Class 2
·Cardiovascular
VNGD SSK PSC INTLK FMRL 60 LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBV·January 27, 2022
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
PRIM SYM SET 2 CL
FDA Adverse Event
Malfunction
·HOSPIRA RICA LTD.·Product code FPA·January 4, 2013
FLEXICAP DISCONNECT CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 20, 2010
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015