11 results · 20ms · Sources: EU EUDAMED, US FDA

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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