15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVOHIP TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NexxZr™ T / D-100-16-NT-D300-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113689·
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981192952·Interbody, 11mm x 32mm x 15mm, 8 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981208066·Trial, 11mm x 32mm x 15mm, 8 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981200947·Interbody, 11mm x 32mm x 15mm, 8 deg
SIGMA STERILIZATION POUCH & ROLL
FDA 510(k)
FDA Class 2
·General Hospital
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
FDA 510(k)
FDA Class 2
·Dental
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 20, 2003
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X360MM X 125°
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·May 29, 2013
IN TOUCH ZU
FDA Adverse Event
Injury
·STRYKER MEDICAL·Product code FNL·June 13, 2011
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 30, 2024
IMP TM 6.0MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 29, 2023
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020