21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILSON-COOK CYSTOTOME
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·March 15, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·February 4, 2019
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2018
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 8, 2019
Reicodent
FDA UDI
devemed GmbH·04061644048731·Insert for
crown remover (Single)
Art No. 2595-...
Reicodent
FDA UDI
devemed GmbH·04061644048748·Insert for
crown remover (Single)
Art No. 2595-...
Reicodent
FDA UDI
devemed GmbH·04061644048755·Insert for
crown remover (Single)
Art No. 2595-...
CBS STRAW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Reicodent
FDA UDI
devemed GmbH·04061644048649·Key for
crown remover (Single)
Art No. 2595-1 /...
Reicodent
FDA UDI
devemed GmbH·04061644048670·Bar for
crown remover (Single)
Art No. 2595-2 /...
Reicodent
FDA UDI
devemed GmbH·04061644048663·Weight for
crown remover (Single)
Art No. 2595-...
Reicodent
FDA UDI
devemed GmbH·04061644048625·Weight for
crown remover (Single)
Art No. 2595-1
Reicodent
FDA UDI
devemed GmbH·04061644048632·Bar for
crown remover (Single)
Art No. 2595-1
TRIDENT 10° X3 INSERT 28MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 27, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 17, 2011
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC.·Product code DSP·April 1, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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