16 results · 28ms · Sources: EU EUDAMED, 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