11 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO SHOULDER FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106143·HOSKIN #28 FORCEPS STRAIGHT
Aurora Anterior Lumbar Plate Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125592·
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
BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 20, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code FMK·May 19, 2008
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 12, 2011
BD VENFLON PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 14, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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