11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Ambient HipVac 50 Wand with Integrated Finger Switches
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
FDA 510(k)
FDA Class 2
·Dental
GRENGLOO
FDA 510(k)
FDA Class 2
·Dental
UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2011
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2008
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014