23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Cabel C1 Bottom Array 3T PH
FDA UDI
Noras MRI products GmbH·04251269204999·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390854634·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390875417·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390889131·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390889148·
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MEDPOR COATED TEAR DRAIN
FDA 510(k)
FDA Unclassified
·Unknown
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390889155·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390889162·
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·September 29, 2015
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 23, 2014
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Death
·SOPHYSA·Product code GWM·November 18, 2024
ZMR AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·April 30, 2018
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020