18 results
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20ms
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Sources: EU EUDAMED, US FDA
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bardia® Coude Olive Tip Urethral Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741039072·Bardia® Coude Olive Tip Urethral Catheter
LEONE SPA
FDA UDI
LEONE SPA·08033707093152·STRAIGHT WIRES SPRING HARD 20x25
FacetLINK MI
FDA UDI
LINKSPINE, INC.·00817329024521·Facet Screw Screwdriver
ACUMED
FDA UDI
Acumed LLC·10806378099908·ARH Slide-Loc™ LRHP Caddy Lid
ROVERS SPATULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010
BARD COUDE TIP LATEX URETHRAL FOLEY CATHETER (TIEMANN MODEL) ONE EYE
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590·Product code EZC·March 9, 2017
BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·October 21, 2022
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011
VERITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·May 9, 2014
6.0MM TI SOFT ROD 500MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNI·October 24, 2012
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·August 17, 2010
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·June 25, 2021
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
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