26 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365107115·
NAMBUCCA Anterior Lumbar Plate Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215019983·
HARDY DISK CLARITHROMYCIN, 15MCG
FDA 510(k)
FDA Class 2
·Microbiology
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS INC.·Product code DYB·November 15, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ARSTASIS, INC.·Product code DYB·November 19, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS, INC.·Product code DYB·November 22, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS, INC.·Product code DYB·November 1, 2010
AFFINITY 4 BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·April 30, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011
PINNACLE FLOOR REPAIR KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FTM·August 7, 2008
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025