16 results · 25ms · Sources: EU EUDAMED, 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