21 results · 18ms · Sources: EU EUDAMED, US FDA

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PERNECZKY ANEURYSM CLIP

FDA 510(k)
FDA Class 2 ·Neurology

VuePoint

FDA UDI
Nuvasive, Inc.·00887517173683·VuePoint Screw, 3.5x12mm Polyaxial Tulip

Para-Pak

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102066·Para-Pak EcoFix is a convenient one-vial system...

Para-Pak EcoFix

FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102400·Para-Pak/Para-Pak ULTRA EcoFix is a convenient ...

Mini Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109904·DB BKT MINI MS LL CUSP 018 T-11 A+7 R2M

METZENBAUM PREPARATION SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·B09929013120·METZENBAUM PREPARATION SCISSORS CURVED DOUBLE-A...

METZENBAUM PREPARATION SCISSORS INSERT

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896007741·METZENBAUM PREPARATION SCISSORS CURVED DOUBLE-A...

HALO MOLAR BAND

FDA UDI
Ortho Arch Company Inc·D90990131213·U67L HALO MOLAR BAND .022 SGL NON-CV -10T BT

PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL

FDA 510(k)
FDA Class 2 ·Radiology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·Product code FPA·July 3, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·Product code FPA·July 3, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·Product code FPA·July 3, 2024

ADULT BREATHING CIRCUIT DUAL HEATED

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014

SETROX S 45

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 2, 2010

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 8, 2013

GMK-SPHERE PATELLA RESURFACING SIZE 1

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 23, 2021

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021