16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric Double Breast Pumps
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566317·CoRoent Ant TLIF PEEK, 15x11x28mm 4°
HHM
FDA UDI
Oticon A/S·05707131288257·H160V2, DESIGNRITE 10 WL VLI HHM
Crosslink Bonding Adhesives
FDA UDI
TP ORTHODONTICS INC·00192029000144·CROSSLINK SMALL PATIENT CAPLT, BLUE COLOR CEMENT
Prolift Post-Pack Instruments
FDA UDI
Life Spine, Inc.·00190837031893·
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00812171029946·ETHOS PRO LABRAL ANCHOR, TITANIUM, 3.3mm x 6mm,...
MD TURBO
FDA 510(k)
FDA Class 2
·Anesthesiology
FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962103746·ETHOS PRO LABRAL ANCHOR, TITANIUM, 3.3mm x 6mm,...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
HARMONIC ACE CURVED SHEARS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 7, 2013
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·June 30, 2011
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014