32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSMED MICROQUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074027722·BONE SCREW 7020745 ILIAC 7.5X45 SS
Safco DENTA-SAFE DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063750180·Light (0.15mm-0.18mm thickness) 6" x 6", green,...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120207451·Carbide, cone flat, excavating and fissure bur
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
TISSUE PROTECTOR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·September 25, 2020
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 18, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 16, 2011
ACE HEAT THERAPY PATCH
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code IMD·March 27, 2008
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
BD PHOENIX SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 6, 2021
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025