16 results · 26ms · Sources: EU EUDAMED, US FDA

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SONOSURG TROCAR

FDA 510(k)
FDA Unclassified ·Unknown

Bard® Nasogastric Sump Tube

FDA UDI
C. R. Bard, Inc.·00801741052262·Bard® Nasogastric Sump Tube

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192862·16mm X 100mm Stem Pilot

XIA SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

FDA 510(k)
FDA Class 2 ·Dental

BARD® NASOGASTRIC SUMP TUBE

FDA Adverse Event
Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code BSS·July 21, 2025

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 9, 2013

INSERTER-LARGE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code LXH·March 28, 2011

SWEET PICOTIP RX

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

UNK - KITS/SETS: FNS IMPLANT KIT

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code MNI·May 4, 2022

ARROW CVC SET: 2-LUMEN 4 FR X 5 CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024

ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023

UNK - KITS/SETS: FNS IMPLANT KIT

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code MNI·May 7, 2022

UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·May 4, 2022

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

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018