2,926 results
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15ms
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Sources: EU EUDAMED, US FDA
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
FDA Enforcement
Class II
·Terminated·Airways Development LLC·December 30, 2015
Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
FDA Enforcement
Class II
·Terminated·Cypress Medical Products LLC·May 15, 2013
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·April 1, 2015
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 11, 2014
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
FDA Enforcement
Class II
·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00
FDA Enforcement
Class II
·Terminated·CME America LLC·November 4, 2020
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
FDA Enforcement
Class II
·Terminated·CoreLink LLC·January 18, 2023
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Enforcement
Class II
·Terminated·QiG Group LLC·March 30, 2016
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
FDA Enforcement
Class II
·Terminated·Sharp Medical Products·April 14, 2021
REGARD Newborn Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Vitrectomy Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Stereotactic Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
REGARD Ear Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
FDA Enforcement
Class II
·Terminated·Sky Medical Supplies and Equipments LLC·February 24, 2021
REGARD Ultrasound Tray
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·November 24, 2021
2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
FDA Enforcement
Class II
·Terminated·Omega Medical Imaging, Inc.·September 14, 2016
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
FDA Enforcement
Class II
·Terminated·Ethicon Endo-Surgery Inc·March 13, 2013