13 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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XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293104·
NON-BR2000 LARGE BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919095262·KM71-233
Bone Screws
FDA UDI
ORTHOPEDIATRICS CORP.·00841132134504·3.5 SCREW CADDY
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 11, 2024
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
FDA 510(k)
FDA Class 2
·General Hospital
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 22, 2013
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 2, 2014
LASSO 2515 NAV VARIABLE CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·April 27, 2011
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