25 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
FDA 510(k)
FDA Class 2
·General Hospital
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964012684·The ENDO CARRY-ON Procedure Kit contains all of...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00141261·
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143261·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001426·artVeneer life lower anteriors, UIL, C4
ARTIFICIAL URRINARY SPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·September 20, 1996
BE 101-00-1426 Tapered Connector
FDA UDI
INSTRUMENTATION INDUSTRIES, INCORPORATED·M996BE1010014260·Tapered Connector - 22mm ID x 27mm ID. Fits com...
3D-MSPECT
FDA 510(k)
FDA Class 2
·Radiology
VIP- VARIABLE INTENSITY POLYMERIZER
FDA 510(k)
FDA Class 2
·Dental
8300 ALARIS ETCO2 MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code CCK·January 10, 2021
8300 ALARIS ETCO2 MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 25, 2020
NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code NJL·March 7, 2013
ENDOSCOPIC BILIARY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code LQR·February 25, 2011
"ICY HOT"
FDA Adverse Event
Injury
·CHATTEM·Product code IMD·February 19, 2008
VERTEBRAL BODY SET/SMALL- STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KWQ·August 9, 2021
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·January 5, 2023
ETHILON NYLON SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·January 5, 2023
Colonoscope, Model Number CF-H180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYG·February 11, 2011
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·September 4, 2013