17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SERUM, CREATININE PHOSPHOKINASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ReLine
FDA UDI
Nuvasive, Inc.·00887517010520·RELINE-C Handle, Torque 26in-lbs
Trimline
FDA UDI
ORMCO CORPORATION·00889989050875·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 15
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189794·AK3 Femoral Sizer
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·SOFTICS (DELTAFILCON A) LENS
Ballancer Gold, 1212
FDA 510(k)
FDA Class 2
·Physical Medicine
NOSECLIP FOR RESP. CARE & PULMON. FUNC.
FDA 510(k)
FDA Class 1
·Anesthesiology
Continuum® Trilogy® Allofit®
FDA UDI
Zimmer, Inc.·00889024152380·
Continuum® Trilogy® Allofit®
FDA UDI
Zimmer, Inc.·00889024152397·
Continuum® Trilogy® Allofit®
FDA UDI
Zimmer, Inc.·00889024152403·
Continuum® Trilogy® Allofit®
FDA UDI
Zimmer, Inc.·00889024152427·
Continuum® Trilogy® Allofit®
FDA UDI
Zimmer, Inc.·00889024152410·
NTLC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 5, 2014
CONSULTA CRT-P
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 15, 2012
COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTUR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·August 2, 2010
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·October 11, 2019
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024