11 results · 36ms · Sources: EU EUDAMED, US FDA

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LUNGPOINT PROCEDURE PLANNING

FDA 510(k)
FDA Class 2 ·Radiology

AMDS Hybrid Prosthesis ("AMDS")

FDA UDI
Artivion, Inc.·00877234001222·55mm – 40mm Tapered Stent (32mm collar)

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

X3 TRIATHLON CS INSERT #3 9MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2022

ROUND FILTER POLYPROVPYLENE

FDA Adverse Event
Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

ARTICUL/EZE BALL 28 +1.5 GR

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code JDI·May 6, 2013

SWARTZ BRAIDED TRANSSEPTAL INT., 8F, SL1

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·April 12, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 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