16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310219013·FG Diamond 368-023 pointed football regular 5/pack
STOMAHESIVE
FDA UDI
CONVATEC, PURCHASING DEPARTMENT·00768455106950·STOMAHESIVE WFR 10X10CM (1X5PK) STER US
Phonak
FDA UDI
Sonova AG·07613275553114·Phonak Virto B30-10
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 8, 2005
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
FDA 510(k)
FDA Class 3
·Cardiovascular
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
FDA 510(k)
FDA Class 2
·General Hospital
Optimotion Blue CR HCCR Total Knee System
FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0219010·CR Tibial Insert, UHMWPE + Vitamin E, Size 2, ...
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·March 26, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·February 25, 2011
BIRD
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 207, INC.·Product code BZR·March 28, 2008
Achieva 1.5T Conversion
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
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
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