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