19 results
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20ms
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Sources: EU EUDAMED, US FDA
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