13 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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BIOSENSORS CENTRAL VENOUS CATHETER KITS
FDA 510(k)
FDA Class 2
·General Hospital
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746104831·BRACKET V-SLOT MEDIUM TWIN LEFT CENTRAL 018 TQ=...
PRIMAFLOW
FDA 510(k)
FDA Class 2
·Dental
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN - HUMERAL TRAY/BASEPLATE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·March 13, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 26, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 1, 2024
SILK SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAP·March 1, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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