15 results
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19ms
·
Sources: EU EUDAMED, US FDA
LIFEBRIDGE
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
Smith & Nephew, Inc.·03596010038593·BONE CURETTE STRAIGHT 228.6MM X
...
Drill bit
FDA UDI
Jeil Medical Corporation·08800089431083·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089466191·
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
FDA 510(k)
FDA Class 2
·Microbiology
DILON 6800 ACELLA (ACELLA)
FDA 510(k)
FDA Class 1
·Radiology
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·May 9, 2013
CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 23, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 9, 2022
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018