12 results
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19ms
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Sources: EU EUDAMED, US FDA
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
FDA 510(k)
FDA Class 2
·General Hospital
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 4, 2013
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011
PUMP MMT-515RNAP PRDGM INS PL EN ML PR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 17, 2008
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024