22 results · 22ms · Sources: EU EUDAMED, US FDA

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OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890105911·Zirlux Implant Analog

Endo Carry-on Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964151316·Endo Carry-on Procedure Kit contains Basin, VIA...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450129210·

Faulhaber Pinzetten KG

FDA registration
Faulhaber Pinzetten KG·33 products·🇩🇪 Germany

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345027961·Lumbar Inserter, PLIF, 7-10H

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0105010·Implant Inserter, 11-13mm, Sleeved

DIMENSION PENTA H, DIMENSION PENTA H QUICK

FDA 510(k)
FDA Class 2 ·Dental

EEG WITH VIDEO, MODEL EX-NW

FDA 510(k)
FDA Class 2 ·Neurology

TRUSTEEL

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·May 26, 2025

TRUSTEEL

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·June 5, 2025

GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 29, 2021

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013

NC QUANTUM APEX PTCA DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 8, 2011

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

BLUNT TIP SCREW, 4X42MM

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 1, 2020

BLUNT TIP SCREW, 4X38MM

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·October 1, 2020

INFLOW TUBING FMS VUE 24PK

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code HRX·March 7, 2025

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 Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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