15 results · 23ms · Sources: EU EUDAMED, 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