16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FTRD System Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROUTMAN NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896074613·TROUTMAN NEEDLE HOLDER WITHOUT LOCK VERY DELICA...
TROUTMAN NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093782·TROUTMAN NEEDLE HOLDER WITHOUT LOCK EXTRA DELIC...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE
Sklar®
FDA UDI
SKLAR CORPORATION·10649111092084·SKLARCUT MAYO SCISS STR 5 1/2"
YOBOSHI DENTAL UNIT
FDA 510(k)
FDA Class 1
·Dental
AMBU BLUE SENSOR NEO AND NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
ESON 2 NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019
SYRINGE 3ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·January 18, 2024
TINBN VANGUARD INT PS ANAT FM R 65MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·March 7, 2025
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 7, 2011
UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA Enforcement
Class II
·Ongoing·Abbott·November 8, 2023
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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