29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
FDA 510(k)
FDA Class 1
·General Hospital
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864661284·Cortex Screw φ2.0 x 22 mm
7600 V MASK
FDA UDI
HANS RUDOLPH, INC.·00874750001408·CAP PLUG PKG 2 HRI SAMPLE PORT
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110477·HALO, 1203-5 VEST PED0, ACRYLIC LINER, 1211-1 M...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001059·Symmetry® Case, Spinal Curette, 7 1/4 in Wide, ...
Cortac
FDA UDI
PMT CORPORATION·00650551144243·Subdural Grid Electrode, Platinum, 22 contacts,...
CORTAC®
FDA UDI
PMT CORPORATION·00650551101529·SUBDURAL ELECTRODE, PLATINUM, 22 CONTACT, 4CM D...
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
InterPulse
FDA UDI
STRYKER CORPORATION·04546540144317·Powerpack- Rechargable
BIOUNIVERSAL PDF
FDA 510(k)
FDA Class 2
·Dental
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cortac
FDA UDI
PMT CORPORATION·00650551144250·Subdural Grid Electrode, 22 Contacts, 4cm Smoot...
CORTAC®
FDA UDI
PMT CORPORATION·00650551114727·SUBDURAL ELECTRODE, PLATINUM, 22 CONTACT, 4CM D...
MONO-DOX
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code NEW·October 4, 2023
MIRROR
FDA Adverse Event
Injury
·CAYENNE MEDICAL·Product code HRY·April 20, 2016
SETROX S 45
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·October 29, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 13, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021