46 results
·
28ms
·
Sources: EU EUDAMED, US FDA
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994990846·CASE 2000026 LEVEL 2
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·September 29, 2023
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 22, 2023
AP233-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, 1.2µ FILTER, NEEDLE
FDA UDI
EITAN MEDICAL LTD·17290109150410·
AC Power Adapter Subassembly Kit
FDA UDI
VITA HEAT MEDICAL·00851446007098·The Model 100026-PA-SA AC Power Adapter Subasse...
SONIALVISON G4
FDA UDI
SHIMADZU CORPORATION·04540217041251·
Olive Wire
FDA UDI
Treace Medical Concepts, Inc.·00810111222167·Olive wire
Midmark IQspiro® Digital Spirometer with Calibration Syringe
FDA UDI
MIDMARK CORPORATION·00841709100338·The IQspiro® Digital Spirometer is intended for...
Mobirex i9
FDA UDI
SHIMADZU CORPORATION·04540217064991·
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132124949·5.0mm Drill Guide
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
Panama™
FDA UDI
FLOSPINE LLC·B1830820000260·2-Level, 26mm Cervical Plate
Panama™
FDA UDI
FLOSPINE LLC·B1830810000260·1-Level, 26mm Cervical Plate
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 4, 2025
END CAP INSERTION ROD SLEEVE A3 NAIL
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HSB·December 22, 2015
BARCOMED 5MP2
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES, INC.·Product code LWQ·June 14, 2001
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE