13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
FDA 510(k)
FDA Class 2
·General Hospital
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980092·DeltaForm HD upper posteriors, L, C1 -MADE IN G...
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102007·
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102489·
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102021·
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102038·
All Purpose Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935102014·
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
FDA 510(k)
FDA Class 2
·Immunology
Intellitorq
FDA 510(k)
FDA Class 1
·Orthopedic
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·February 27, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 7, 2011
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022