18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
FDA 510(k)
FDA Class 1
·General Hospital
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004007·ELEVATOR 79S
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964023123·The ENDO CARRY-ON Procedure Kit contains all of...
3M™ Unitek™ APC™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221236968·APC FF Clarity Ultra SL MBT L Lt Cuspid 0T/3A D...
3M™ Unitek™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221287328·Clarity Ultra SL Bkt MBT L Lt Cuspid 0T/3A DHk 022
ELECSYS CA 15-3 CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PROSTHESIS, HIP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021
TENDRIL STS
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 24, 2025
TENDRIL STS
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 24, 2025
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
OSTEOTOME STRAIGHT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWM·February 28, 2013
PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011
EPIDURAL MINIPACK
FDA Adverse Event
Injury
·SMITHS MED INT'L LTD.·Product code CAZ·February 15, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
FDA Enforcement
Class I
·Terminated·Abbott·May 23, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024