15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
Kroger
FDA UDI
KROGER CO., THE·00011110381033·KROGER 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETE...
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LIFENET SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·May 14, 2013
HEXOKINASE, GLUCOSE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CFR·June 3, 2011
SM PLUS SBT/ROUND BALLOON DISSECTOR
FDA Adverse Event
Malfunction
·NORTH HAVEN - USS·Product code GCJ·August 11, 2008
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·September 15, 2020
NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·July 18, 2023
AMISTEM-P
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 2, 2025
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023