15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
FDA 510(k)
FDA Class 2
·Immunology
KATOR, LLC
FDA UDI
KATOR, LLC·B18610305900·KATOR Suture Anchor, Open, 5.0mm x 20mm, #2 Suture
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074195865·PROXIMAL SCREW 5.5 X 90, SS
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305901·Diamond, cone round, medium grit
NA
FDA UDI
STERILMED, INC.·10888551033367·BUR PRECISION ACORN
NA
FDA UDI
STRYKER CORPORATION·07613154883165·9.0mm Precision Acorn
GRAMS POLYESTER NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LATERAL PIVOT INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
PROXIMATE** RELOADABLE LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2013
ONE TOUCH
FDA Adverse Event
Injury
·LIFESCAN·Product code FMK·March 24, 2011
ARCHITECT I2000 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC·Product code LOJ·April 16, 2008
ACE LINR-NEUT-40X58/60 RESTORIS XLVE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OQG·November 24, 2015
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016