21 results · 21ms · Sources: EU EUDAMED, 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