11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
FDA 510(k)
FDA Class 2
·Hematology
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308280·10mm Drill Spacer 5mm
8 x 28mm Citrelock ACL Implant
FDA UDI
Acuitive Technologies, Inc.·00810027270603·
EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HRY·July 31, 2025
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
VASO PRESS DVT FOOT GARMENT #VP 520
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069630589·COMPASS GPS V2.1, USB plug
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 4, 2011
IPUMP PAIN MANAGEMENT SYSTEM US VERSION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD·Product code FRN·April 17, 2008
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