23 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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ANNULOFLO SYSTEM, MITRAL MODEL AR700
FDA 510(k)
FDA Class 2
·Cardiovascular
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005497·COSMETIC 20/40 UPPER CEN 018 T=0 A=0 R=0
NA
FDA UDI
Conmed Corporation·10845854006818·5.3MM BUR, TREPHINE (RED) FOR USE WITH LOW OR M...
Reicodent
FDA UDI
devemed GmbH·04061644053346·Haemostatic forceps 1x2 | 125 mm
"Halstead-Mosq...
Reicodent
FDA UDI
devemed GmbH·04061644049639·Haemostatic forceps | 125 mm
"Halstead-Mosquito...
UD-1000 ULTRASONIC A/B SCANNER
FDA 510(k)
FDA Class 2
·Radiology
RX EVEREST
FDA 510(k)
FDA Class 2
·Dental
FOOT CONTROL, SC2100
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 20, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·March 26, 2008
HYDRUS MICROSTENT
FDA Adverse Event
Injury
·IVANTIS INC·Product code OGO·October 10, 2024
HYDRUS MICROSTENT
FDA Adverse Event
Injury
·IVANTIS INC·Product code OGO·October 9, 2024
HYDRUS MICROSTENT
FDA Adverse Event
Injury
·IVANTIS INC·Product code OGO·October 9, 2024
CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG)
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NDP·November 3, 2021
HYDRUS MICROSTENT
FDA Adverse Event
Injury
·IVANTIS INC·Product code OGO·October 9, 2024
ARTISYN Y-SHAPED MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·September 30, 2024
POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·September 30, 2024
GYNECARE GYNEMESH M UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAL·September 30, 2024
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·May 5, 2023
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