19 results · 20ms · Sources: EU EUDAMED, US FDA

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PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN

FDA 510(k)
FDA Class 1 ·Anesthesiology

Bioplate®

FDA UDI
Bioplate, Inc.·M3848120660·Self-Drilling Screw - Ø1.5 mm x 4 mm

Bioplate®

FDA UDI
Bioplate, Inc.·M384812066US0·Self-Drilling Screw - Ø1.5 mm x 4 mm

Bioplate®

FDA UDI
Bioplate, Inc.·M384812066CP1·Self-Drilling Screw - Ø1.5 mm x 4 mm

EZout

FDA UDI
STRYKER CORPORATION·07613327294514·Blade Pack, 66mm

PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·February 4, 2021

8100 PUMP MODULE 9.1.17.7

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 17, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 15, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 28, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 12, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 7, 2021

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014

CONSULTA CRT-D

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·August 18, 2010

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018