12 results
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25ms
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Sources: EU EUDAMED, US FDA
THE COMPANION NON-ELECTRIC LIFT CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
3M™ Unitek™
FDA UDI
3M COMPANY·30605861012851·3M™ Unitek™ Stainless Steel Crowns - Permanent ...
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test
FDA UDI
Hemagen Diagnostics, Inc.·G522902600·For the detection and titration of HSV-2 IgG an...
Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok™ Sampling Port
FDA UDI
C. R. Bard, Inc.·00801741029127·Bard® 350ml Urine Meter Foley Tray with Bard EZ...
Sklar
FDA UDI
SKLAR CORPORATION·10649111446603·SCHINDLER PERITONEAL CLP FCP8 INCHES
LITWIN CRUICATE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULISA PR3 ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 30, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 18, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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