43 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Akesis Galaxy RTx
FDA 510(k)
FDA Class 2
·Radiology
INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASK
FDA UDI
Intersurgical Incorporated·05030267100552·INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASK
GoPLF! Posterior Lateral Fusion Device
FDA UDI
GetSet Surgical SA·07640387660188·GoPLF! Posterior Lateral Fusion Device, 5.5mm x...
STEVENS TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054349·STEVENS TENOTOMY SCISSORS STRAIGHT SHORT BLUNT ...
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2522000500·Straight Titanium Rod
TAURUS
FDA UDI
CTL Medical Corporation·00841732150836·5.5mm Straight Rod 50mm Ti Alloy
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555252200050·Taurus Pedicle Screw System- Straight Rod 5.5x50mm
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555102200050·Straight Rod 6.0mm, 50mm
CorticaLINK MI
FDA UDI
LINKSPINE, INC.·00817329023005·5.0mm Cobalt Chrome Rod: 50mm Curved
ENAMEL BONDING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SMR HUMERAL HEAD Ø50 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·February 12, 2024
PRECISE RX NITINOL STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIM·October 15, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 10, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013
TRILOGY LINER 0DG 50 X 28
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·January 30, 2018
VERSYS FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·January 30, 2018
FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 0 105 MM STEM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·January 30, 2018
Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009
Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
FDA Recall
Terminated
·MMS Sales Corp·Product code CAI·February 21, 2005