20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOIST PUNCTAL PLUG SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Safco FG Composhape Finishing Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310219363·FG Diamond 390-014 football extra fine (yellow)...
PORTUX CAD/CAM Disc. 98.5X18mm A1. MN
FDA UDI
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A·07701126712183·PORTUX CAD/CAM Disc. 98.5X18mm A1. MN
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788021175·Spirol® Close End 19g x 36" Epidural Set, Styl...
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010
MODIFIED KUGEL PATCH
FDA Adverse Event
Malfunction
·DAVOL INC.·Product code FTL·September 1, 2011
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·March 26, 2013
SARNS CENTRIFUGAL PUMP
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·March 7, 2011
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT PRECOAT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·March 28, 2008
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·August 2, 2011
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017