21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SULTAN SPOROX TEST VIAL, MODEL 75195
FDA 510(k)
FDA Class 2
·General Hospital
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040162160·Channels Flex Gutta Percha Points 20.04
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717108214·Midway Select Kelly Scissors 6 1/4" Straight
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106120·Trial, 26 x 12mm, 8 Degree, Tapered, Straight
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113379·PS Insert, Size 6 x 12mm
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231284·Unitek Miniature Twin MBT LL 1Bi -12T/2A DHk 01...
Symmetry Wagner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482046159·Symmetry® Scissors, Wagner, Straight, Sharp/Sha...
BD NOKOR¿ FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·September 17, 2018
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLARIS
FDA UDI
HNM TOTAL RECON LLC·00841742113555·POLARIS ø2.0mm Snap-Off Screw, Ti - (L)12mm
BD NOKOR¿ FILTER NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·August 6, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2025
Octane C
FDA UDI
Choice Spine, LP·10885862007407·
MINIMARK DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO., INC.·Product code DZE·March 21, 2013
POLY G-OMCP-VISUB-CCD (H5000)
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 10, 2011
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·CYTYC SURGICAL PRODUCTS·Product code MNB·March 28, 2008
ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC
FDA Adverse Event
Injury
·DORNOCH·Product code JCX·October 30, 2015
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·August 8, 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