19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
EQUIA
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217801·
NA
FDA UDI
STERILMED, INC.·10888551021050·BUR SIDE CUTTING MEDIUM TAPERED
TMW
FDA UDI
HERAEUS MEDICAL COMPONENTS LLC·00816840020395·
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 9, 2003
STONELITH, MODEL V5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
FDA 510(k)
FDA Class 2
·General Hospital
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2020
GAS MODULE II
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
OLYMPUS AUXILIARY WATER TUBE
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDS·May 5, 2011
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.
FDA Recall
Terminated
·Medtronic Inc. Cardiac Rhythm Managment·Product code DPS·February 2, 2006
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012