17 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALLON 2001 VERSION 5
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690113928·PS-R Insert, Size 1 x 28mm
Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
FDA UDI
CURITEVA, INC.·B648C72430241281·30 (W) X 24 (D) X 12 (H) X 8° (A) STANDALONE AL...
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CANDELA SMOOTHBEAM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 9, 2024
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·December 12, 2008
ROD FOR REAMING GUIDE HOLDER
FDA Adverse Event
Malfunction
·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575·Product code LXH·January 15, 2016
GLENOSPHERE ORIENTATION GUIDE
FDA Adverse Event
Malfunction
·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575·Product code LXH·January 13, 2016
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 27, 2013
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 11, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
IMPELLA RP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code PYX·May 7, 2024
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 7, 2024
BD ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 11, 2024
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 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