15 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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STAT PROFILE CRITICAL CARE XPRESS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Reicodent
FDA UDI
devemed GmbH·04061644048960·Diamond plated insert for
telescopic crown plie...
Reicodent
FDA UDI
devemed GmbH·04061644048977·Diamond plated insert for
telescopic crown plie...
Reicodent
FDA UDI
devemed GmbH·04061644048946·Telescopic crown pliers
consisting of:
Reicodent
FDA UDI
devemed GmbH·04061644048939·Telescopic crown pliers
consisting of:
Reicodent
FDA UDI
devemed GmbH·04061644048953·Telescopic crown pliers
consisting of:
ICE BATON
FDA 510(k)
FDA Unclassified
·Unknown
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
FDA 510(k)
FDA Class 1
·General Hospital
LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2023
MMF SCREW
FDA Adverse Event
Injury
·KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG·Product code DZL·March 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011
CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·March 27, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017