15 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100600·Caddie, Modular Bone Screws
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862233141·INSTRUMENT TRAY, LOGIC CRC, SIZE 6
Zyphr
FDA UDI
STRYKER CORPORATION·04546540517463·6.0mm Zyphr Extended Round Fluted
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 10, 2018
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
FDA 510(k)
FDA Class 2
·Radiology
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code MSS·March 4, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015