21 results
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18ms
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Sources: EU EUDAMED, US FDA
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