27 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
FDA 510(k)
FDA Class 2
·Orthopedic
XLIF
FDA UDI
Nuvasive, Inc.·00887517181800·XLIF Thoracic Instr Tray Insert - Base
ReLine
FDA UDI
Nuvasive, Inc.·00195377047267·RELINE-O Trial, 7mm H TP W L-pop
OsteoMed
FDA UDI
OSTEOMED LLC·00845694005807·3 Prong Mini Plate Bender
POTTS SMITH FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896100060·POTTS SMITH FORCEPS TUNGSTEN CARBIDE SERRATED TIP
10M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457203698·Conical BL
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898307553·MXHO LINER 22-66/70
DRG AURICA ELISA TESTOSTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
FDA 510(k)
FDA Class 2
·Orthopedic
Keos Lumbar Instrument
FDA UDI
KEOS·B0842002000430·
EZout
FDA UDI
STRYKER CORPORATION·07613327175905·Centering Plug
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 10, 2011
COLLAGEN COATED POLYESTER VASCULAR GRAFT
FDA Adverse Event
Malfunction
·INTERVASCULAR·Product code DSY·July 23, 2008
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 1, 2013
SWING BREAST PUMP
FDA Adverse Event
Injury
·MEDELA AG·Product code HGX·August 26, 2011
PUMP IN STYLE BREAST PUMP
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·March 31, 2011
PUMP, BREAST, POWERED
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·March 10, 2011
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018