26 results · 23ms · Sources: EU EUDAMED, US FDA

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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