BEUDAMED
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    NUVASIVE NVM5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ArgenPMMA 95x25-B2

    FDA UDI
    ARGEN CORPORATION, THE·D818123307·Crown And Bridge, Temporary, Resin

    75H - PG&E Class B 21 BBP

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233079·PG&E Class B 21 BBP - 75H

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180169708·Castroviejo Corneo Forceps Angled Non-Insulated

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981326135·Trial, 14x13mm, 10° Lordosis, 7mm Height, w/o D...

    MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMISTEM H CEMENTLESS STEM SIZE 3 STD

    FDA Adverse Event
    Other ·MEDACTA INTERNATIONAL, SA·Product code LZO·December 19, 2014

    STEM: AMISTEM H COATED STD STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 9, 2020

    STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 7, 2019

    TI PANGEA(TM) LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·May 21, 2013

    SGL TRIG PIN COLLET 2.0-3.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 8, 2011

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    ECHO BI-METRIC

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 5, 2025

    BD INTRAOSSEOUS NEEDLE SET KIT

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code FMI·March 11, 2022

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)

    FDA Enforcement
    Class I ·Ongoing·Bard Access Systems, Inc.·August 3, 2022

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021