10 results
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17ms
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Sources: EU EUDAMED, US FDA
FILE TYPE K ENDODONTIC
FDA 510(k)
FDA Class 1
·Dental
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
FDA 510(k)
FDA Class 2
·Orthopedic
SOL-CARE SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·February 28, 2014
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code JDI·October 26, 2012
SERIES 20000 LEGACY
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 27, 2010
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·July 24, 2024
BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024