16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
FDA 510(k)
FDA Class 2
·Immunology
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004113·ELEVATOR 34 (12)
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
SCANLAN® Legacy Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159032840·Legacy Titanium Needle Holder, FH W/RAT 7" Reg BL
ACCESS ALERT GAUGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E-Z LINK CROSS CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 20, 2024
1.5MM/1.1MM DOUBLE DRILL SLEEVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·February 28, 2013
EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011
ICY HOT AIR ACTIVATED NECK
FDA Adverse Event
Other
·*·Product code IMD·February 22, 2008
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022