19 results
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19ms
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Sources: EU EUDAMED, US FDA
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CTXA Hip Bone Mineral Densitometer
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002143·artVeneer life lower posteriors, L, D3
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00271431·
Nanda Braided Copper NiTi
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20021431·Nanda Braided copper-nickel-titanium archwires ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180242·
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167900021430·
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167S1900021430·
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 14, 2011
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·February 24, 2026
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 13, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·February 25, 2008
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020