BEUDAMED
    1,777 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles) Product Usage - Eye contact lens

    FDA Enforcement
    Class II ·Terminated·Intertrade Imports Inc.·January 21, 2015

    ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·January 24, 2018

    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·November 28, 2018

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 5, 2019

    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020

    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·December 16, 2020

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·August 14, 2019

    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·July 29, 2020

    Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·December 26, 2012

    BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·December 18, 2013

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    FDA Enforcement
    Class II ·Terminated·TEM Systems Inc·March 16, 2016

    Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·June 12, 2013

    LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.

    FDA Enforcement
    Class II ·Terminated·Physio-Control, Inc.·February 15, 2017

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·November 25, 2015

    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012