21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M22 and ResurFx Systems
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCOVILLE LUMBAR BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896096202·SCOVILLE LUMBAR BLADE
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190066·EAG Ankle Clamp w/ Spring
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004572·SpectrumTM Short Malar Anchor Assembly
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
Ø3.5mm x 60mm Precontoured Cervical Rods
FDA UDI
XENCO MEDICAL LLC·B064XM21700601·
ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES PR·Product code JXG·September 22, 2017
Ø3.5mm X 60mm PRECONTOURED CERVICAL RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21700602·
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
FDA 510(k)
FDA Class 2
·Cardiovascular
GALASHAPE 3D
FDA Adverse Event
Injury
·TEPHA, INC.·Product code OOD·November 13, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
RECONSTRUCTION NAIL R1.5, TI, LEFT 11X380 MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 13, 2011
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013
XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 14, 2014
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023