16 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAICHEM LIPID CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVELIFE
FDA UDI
CONVATEC, PURCHASING DEPARTMENT·00768455101573·Activelife® One-Piece Drainable Pre-Cut Pouch W...
Ligatures
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746077333·LIGATURE 20 STICK LIME 50/BAG
Ligatures
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156144·LIGATURE 20 STICK LIME 50/BAG
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 28, 2008
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSO·May 2, 2023
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 2, 2016
PLATE BBL CHROMAGAR MRSA II 90MM 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 28, 2021
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