23 results · 22ms · Sources: EU EUDAMED, 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