20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BAYER ADVIA CENTAUR HER-2/NEU ASSAY
FDA 510(k)
FDA Class 2
·Immunology
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50240171·Rotary instrument für surgical application
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751873·Sterile Single Use Burs - ISO Code 878-012C
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252024017·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...
H-SCRIBE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013
NAVILYST/EXODUS
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL·Product code FGE·March 14, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
CORTICAL FXATION FXD LOOP 15MM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL·Product code MBI·July 23, 2025
INTRAFIX PEEK TPR SCR, 7-9MMX30MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MBI·July 23, 2025
TRUESPAN 12 DEGREE PEEK
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL·Product code MBI·July 23, 2025
INTRAFIX PEEK TPR SCR, 6-8MMX30MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MBI·July 23, 2025
MILAGRO ADVANCE SCREW 8X30MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·July 23, 2025
TRUESPAN 24 DEGREE PEEK
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL·Product code MBI·July 23, 2025
MILAGRO ADVANCE SCREW 8X23MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·July 23, 2025
INTRAFIX TAPERSCR 8-10X30MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MBI·July 25, 2025
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018