22 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M
Callaly Tampliner
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694019149·1.2mm Fully Threaded Screw Drill Guide
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869611794·MOSS VRS rod rotation key
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130306·Knee Instrument Case 3 Base
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130313·Knee Instrument Case 3 Tray
Howmedica, Mix-Kit
FDA UDI
STRYKER CORPORATION·04546540257802·I Disposable Mixing Bowl and Spatula
Z-NET
FDA 510(k)
FDA Class 1
·General Hospital
RAPIDVIT BLAST, RAPIDWARM BLAST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·October 29, 2018
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
M2A-MAGNUM MOD HD SZ 42MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 2, 2013
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
QUIDEL QUICK VUE OTC COVID 19 TEST
FDA Adverse Event
Malfunction
·QUIDEL CORP.·Product code QKP·January 17, 2024
QUIDEL QUICK VUE OTC COVID 19 TEST
FDA Adverse Event
Malfunction
·QUIDEL CORP.·Product code QKP·January 17, 2024
Quanta System Sterile Optical Laser Fiber, reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016