16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N LATEX IGA
FDA 510(k)
FDA Class 2
·Immunology
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 38mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008807·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410240380·Anterior Closing Wedge Osteotomy Guide, 24mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420240380·Anterio Lateral Closing Wedge Osteotomy Guide, ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420240400·Anterio Lateral Closing Wedge Osteotomy Guide, ...
PYLORITEK VP TEST KIT 5140VP
FDA 510(k)
FDA Class 1
·Microbiology
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
FDA 510(k)
FDA Class 2
·Clinical Chemistry
25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·October 2, 2015
SPECTRUM IQ
FDA Adverse Event
Malfunction
·BAXTER INTERNATIONAL INC.·Product code FRN·July 28, 2022
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013
ARTHREX
FDA Adverse Event
Malfunction
·ARTHREX·Product code LXH·March 2, 2011
FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 5, 2008
NV CROWN CUP CLSTR HOLE 48MM GROUP 1
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 21, 2025
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
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018