14 results · 21ms · Sources: EU EUDAMED, US FDA

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RAMP RSV ASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780835·LEVAMED ACTIVE ANKLE SUP SLVR R V

Gen. Acces/ Instr. Tip Guard

FDA UDI
KATENA PRODUCTS, INC.·00841668110874·TIP GUARDS VENTED GREEN PACK OF 100

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450270523·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450253182·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112350·Tap, 7.50mm, Fixed Sleeve

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

FDA Enforcement
Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500

FDA 510(k)
FDA Class 2 ·Hematology

OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 13, 2026

V SERIES MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

REVERE PEDICLE SCREW

FDA Adverse Event
Injury ·GLOBUS MEDICAL, INC.·Product code MQP·August 18, 2014

GYNNIE OB-GYN STRETCHER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code HDD·April 20, 2011

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