23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925017016·RICHARDS RIBBON LOOP 5.25 MM LENGTH PLATINUM
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649637·INTREPED 08 Universal Depth Stop
GEN4 DIRECT ACCESS
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828195379·
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828190923·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828158930·GEN4 INTERACTIVE
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828127417·GEN4 Direct Access
Foot Osteotomy Wedge System
FDA UDI
Tyber Medical, LLC·M6951407080·CerviFuse Lordotic Spacer, 11 x 14 x 8mm
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
STATUS FIRST STREP A
FDA 510(k)
FDA Class 1
·Microbiology
PALINDROME 55/72 KIT W/ SLOT
FDA Adverse Event
Malfunction
·COSTA RICA·Product code MPB·October 3, 2014
TRIATHLON ASYMMETRIC X3 PATELLA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 31, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 15, 2011
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 28, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·August 24, 2016