11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DSG RELAXER SPLINT
FDA 510(k)
FDA Unclassified
·Unknown
Safco economy saliva ejectors
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310226273·Safco economy saliva ejector white
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
ETS - ENDOSCOPIC LINEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 27, 2013
VISIONAIRE TIBIA GI
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code EKD·March 17, 2011
SEQUOIA SCREWDRIVER MODULAR
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code HXX·March 31, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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