15 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FOOT BATHS & HAND MASSAGERS
FDA 510(k)
FDA Class 2
·Physical Medicine
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334012380·McCrea Female Sound, Curved
24M - Safety General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588100340·24M - Safety General Purpose
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left
CH-200
FDA UDI
SHIMADZU CORPORATION·04540217031436·
UniTip Catheter
FDA UDI
Unisensor AG·07640172972090·
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
FDA 510(k)
FDA Class 2
·General Hospital
Weinmann Tracheostomy Exchange Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·EYERISOL(R)
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·EYERISOL(R)
VORTX? - 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·May 14, 2014
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 31, 2012
BD 31G X 8MM PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·August 12, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024