18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
FDA 510(k)
FDA Class 2
·General Hospital
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223115237·Needle
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223104453·Distal Tip: SPROTTE®
Proximal End: ISO 80369-7
SPROTTE® 2.G
FDA UDI
Pajunk GmbH Medizintechnologie·14048223024284·SPROTTE® 2.G
Standa...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450142523·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197500562·Vascular DeBakey Forceps
Ø5mm, ...
SNIPER, MODEL OR-3872XX SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
SPARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
ADVISA DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A. (SMO)·Product code NVZ·April 10, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 22, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NFA·December 2, 2008
CELL-DYN RUBY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023
HENRY SCHEIN
FDA Adverse Event
Malfunction
·A.R. MEDICOM INC. (SHANGHAI) LTD.·Product code FXX·December 12, 2016
HENRY SCHEIN SOFT EARLOOP FACE MASK
FDA Adverse Event
Other
·A.R. MEDICOM·Product code FXX·July 27, 2012
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018