12 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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Triever20 Curve Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Bio-logic
FDA UDI
NATUS MEDICAL INCORPORATED·00382830000833·OAE 6mm Blue Ear Tip
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STICK
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2024
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·October 15, 2008
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
VASSALLO GT
FDA Adverse Event
Injury
·FILMECC CO., LTD.·Product code DQX·October 3, 2024
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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