21 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OsteoMed Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131282811·H110V2, BTE 13 WL 100 CNB HHM
AGC Tradition Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304008212·
Release Module
FDA UDI
ORMCO CORPORATION·00889989059878·Release Module Heavy Force
N/A
FDA UDI
Smith & Nephew, Inc.·00817470009002·STRAIGHT PICK
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510210·Threaded Fixation Pin, ø3mm x 210mm
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
FDA 510(k)
FDA Class 2
·Cardiovascular
CUBESCAN / BIOCON-700
FDA 510(k)
FDA Class 2
·Radiology
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 14, 2017
MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +5MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWY·June 29, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code NBW·August 29, 2008
BELLAFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·January 11, 2024
Biograph mMR. Model Number: 10433372.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 29, 2019
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 8, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016