13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KA01 Chitosan Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV
ALN OPTIONAL VANA CAVA FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
CGUARD PRIME CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·INSPIREMD LTD.·Product code NIM·October 2, 2025
CGUARD PRIME CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·INSPIREMD LTD.·Product code NIM·October 2, 2025
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code MXC·January 13, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 3, 2013
UNKNOWN
FDA Adverse Event
Other
·BREG, INC·Product code ILO·June 20, 2011
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 10, 2025
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 7, 2023
PKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014