15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ULTIMUM EV HEMOSTASIS INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583021943·Coverall, GenPro, White, Inset Sleeve, Zip Clos...
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G22314032750·Bailey Lachrymal Cannula 25ga with 19ga x 4mm R...
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
HEARTWAY POWER CHAIR, P23
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
FDA 510(k)
FDA Unclassified
·Unknown
TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2021
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·September 29, 2025
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·May 31, 2013
SELOX ST 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·June 17, 2011
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·December 17, 2014
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 3, 2016
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019