19 results · 20ms · Sources: EU EUDAMED, US FDA

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KNIGHTSTAR 330 VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

TRIALTIS

FDA UDI
Medos International Sàrl·10705034592060·TRIALTIS Spine System Tap,Short 7.5mm 3-10cm ± 1%

RIVA Posterior Fixation System

FDA UDI
XENIX MEDICAL LLC·00840493414201·Pedicle Tap, 7.5mm

Arsenal

FDA UDI
ALPHATEC SPINE, INC.·00840967169729·NARROW BLADE THORACIC INFRALAMINAR HOOK, 7.5mm

Arsenal

FDA UDI
ALPHATEC SPINE, INC.·00840967161716·NARROW BLADE THORACIC INFRALAMINAR REDUCTION HO...

ZYDERM 1 COLLAGEN IMPLANT (1.0ML)

FDA Adverse Event
Injury ·MCGHAN MEDICAL CORP.(FERMONT)·Product code LMH·March 23, 2001

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130535·7.5mm Screw Caddy

RANDOX CALCIUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACE SDS 3.75MM SCREW DENTAL IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

INSET GUARD

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

NA

FDA UDI
Zimmer, Inc.·00889024065895·

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 13, 2013

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·February 28, 2011

2250051-2008-00093

FDA Adverse Event
Malfunction ·Product code JTC·February 11, 2008

CARDIOSAVE HYBRID, TYPE I PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 18, 2025

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

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

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

FDA Enforcement
Class I ·Terminated·Abbott·May 23, 2018

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024