14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HSA-SOLUTION, MODEL 10034/10064
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310218963·FG Diamond 368-023 pointed football regular ss ...
ALBERT BROWNE LTD.
FDA registration
ALBERT BROWNE LTD.·10 products·🇬🇧 United Kingdom
ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
FDA Adverse Event
Malfunction
·MINNTECH CORP.·Product code NVE·March 31, 2009
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
FDA 510(k)
FDA Class 2
·Cardiovascular
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TARGETING ARM PROX. LAT. TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
WINGSET PBBCS 21 X .75 12 PREATTACHED
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 3, 2017
PFC SIGMA FEM POST AUG SZ4 4MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code JWH·March 26, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·March 31, 2008
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