13 results
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19ms
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Sources: EU EUDAMED, US FDA
CARDIOTRAC CORNING CK ISOENZYME SUBST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135730·Straight Plate - Ø1.5 mm - 2 hole - 14 mm (3), ...
Bioplate®
FDA UDI
Bioplate, Inc.·M384813573US0·Straight Plate - Ø1.5 mm - 2 hole - 14 mm (3), ...
Vstrip H. pylori Antigen Rapid Test
FDA 510(k)
FDA Class 1
·Microbiology
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 9, 2013
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 21, 2024
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007
Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025