19 results
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28ms
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Sources: EU EUDAMED, US FDA
SS MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
OrthAlign Plus
FDA UDI
Orthalign, Inc.·00851977007673·Lid, Tray, 10x10
NOBELREPLACE CC RP 5.0X8MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·June 29, 2023
POLARIS
FDA UDI
HNM TOTAL RECON LLC·00841742113371·POLARIS ø4.0mm/ø3.0mm High Compression Screw, C...
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107188·WAGNER SCISSORS, 4 3/4", SHARP/BLUNT, CVD
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
FDA 510(k)
FDA Class 2
·Cardiovascular
STRYKER NAVIGATION SYSTEM - ENT MODULE
FDA 510(k)
FDA Class 2
·Neurology
SPACELABS MODEL 90207 ABP MONITOR
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code DXN·June 3, 2015
VALIANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·January 11, 2021
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 11, 2021
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 11, 2021
TALENT TAA STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·January 11, 2021
PROLITE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·March 18, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 16, 2011
JOSTENT CORONARY STENT GRAFT
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 27, 2008
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
SPACELABS MODEL 90207 ABP MONITOR
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code DXN·September 18, 2015
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