BEUDAMED
    143 results · 27ms · Sources: EU EUDAMED, US FDA

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    ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111022890·CRILE HEMOSTAT STR 7 1/2

    FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Dental

    EMBRYO VIEWER SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 15, 2014

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·June 17, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2011

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·December 13, 2024

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·October 24, 2024

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·October 17, 2023

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GBO·October 11, 2021

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 1, 2024