BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYNTHES MULTILOC HUMERAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159624·PROTECT.GENU KNEE SUPPORT GRAY VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236326·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521208070·

    MICROPUNCTURE

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DYB·November 23, 2016

    MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 20, 2013

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    TRANSCEND QUADRANT SHELL

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 15, 2008

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016

    Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·August 8, 2005

    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018