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

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BIOPATCH ANTIMICROBIAL DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

Premier Cavity Prep

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008302·BLACK CUTTING INSTR 63/64

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00312291·

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159003031·Jacobson Micro Needle Holder Flat Handle

WACKERS-LIU CQ SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CHRONOS STRIP 100*25*3

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code MQV·October 4, 2012

BIO-CORKSCREW SUTURE ANCHOR

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·February 28, 2011

TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD

FDA Adverse Event
Malfunction ·SMITHS MEDICAL, ASD.·Product code DRS·February 21, 2008

VARISOFT

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

VARISOFT

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

VARISOFT

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024