16 results · 20ms · Sources: EU EUDAMED, US FDA

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MIZAR, BASIS BE, SANDMAN DIGITAL

FDA 510(k)
FDA Class 2 ·Neurology

Premier Crown Removers

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783010138·CROWN REMOVER POINT 3

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159008579·Micro Suture Tying Forceps, RH, str DD platform...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450382998·

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159018912·TITANIUM MICR SUTURE TYNG FCEPS RND HNDL STRT P...

SCANLAN® Titanium Neuro Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159011944·Micro Suture Tying Fcp, RH, Gerald type taper, ...

SCANLAN® Titanium Neuro Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159036251·Micro Suture Tying Fcp, RH, Gerald type taper, ...

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

LSL (ITEM 1620M)

FDA Adverse Event
Malfunction ·CARDINAL PRIME VENDOR·Product code KOD·April 24, 2012

OT VERIO IQ METER

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

ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL)

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code DEW·February 4, 2011

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·August 12, 2014

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

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

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