15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Symani Surgical System (820-03830)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SonicPro Ultra Sensitive Electric Toothbrush Replacement Head
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755383·SonicPro Ultra Sensitive electric toothbrush re...
NA
FDA UDI
Synaptic Medical, Ltd.·06948806313921·Cable, Electrode
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016302·
Stainless Steel Round Wire
FDA UDI
Ortho Arch Company Inc·D9092500141·.014 STAINLESS STEEL ROUND LENGTHS (10)
FG Dental Burs
FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119312122·
HEMONIR TM
FDA 510(k)
FDA Class 2
·Hematology
Serenity
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SABER014
FDA Adverse Event
Malfunction
·CORDIS US CORP·Product code LIT·March 9, 2026
SABERX014
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code LIT·August 22, 2025
ACCU-CHEK RAPID D INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 14, 2008
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 15, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 26, 2013
BIOABSORBABLE INTERFERENCE SCREWS
FDA Adverse Event
Injury
·S.B.M. SAS·Product code MAI·January 22, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013