19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PARA 12 PLUS RETICS
FDA 510(k)
FDA Class 2
·Hematology
Essential Kit
FDA UDI
MEDIVATORS INC.·40677964008700·Essential Kit includes Olympus DEFENDO Valves, ...
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092179253·NobelActive™/Conical-compatible RP Scan Body
Ki...
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361008248·PedFuse ReTurn, Hex, CNL, 9.0mm x 45mm
Synergy Disc Instruments
FDA UDI
Synergy Spine Solutions Inc·M67091000009450·Trial, Medium, 5mm, 6°
CARDIOSAVE HYBRID, TYPE G PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 28, 2025
COMFORT
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 26, 2026
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
POSITUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MINIMED SILHOUETTE
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 31, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·February 18, 2011
LADARVISION
FDA Adverse Event
Injury
·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·February 20, 2008
BENCHMARK GX, STAINER MODULE
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 12, 2024
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024