19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741188039·Catheter Placement Kit
Essential Kit
FDA UDI
MEDIVATORS INC.·40677964008328·Essential Kit includes Brush, Air/Water, Suctio...
Synergy Disc Instruments
FDA UDI
Synergy Spine Solutions Inc·M67091000009260·Trial, Small, 6mm, 6°
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 16, 2025
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 16, 2025
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
FDA 510(k)
FDA Class 2
·Cardiovascular
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 24, 2026
OXFORD CEMENTLESS TIBIA B LM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HRY·June 29, 2018
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
UNKNOWN ZIMMER MIS TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 18, 2011
LADARVISION
FDA Adverse Event
Injury
·ALCON-ORLANDO TECHNOLOGY CENTER·Product code LZS·February 20, 2008
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 19, 2025
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024