13 results · 21ms · Sources: EU EUDAMED, US FDA

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VAPOR CERAMIC BRACKET

FDA 510(k)
FDA Class 2 ·Dental

CoRoent

FDA UDI
Nuvasive, Inc.·00887517574787·CoRoent Ant TLIF Ti, 13x12x36mm 8°

HHM

FDA UDI
Oticon A/S·05707131258205·H150, RITE 312 WL DBL HHM

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102671·CHANG COMBINATION CHOPPER, RIGHT

SONOMA ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NON-ABLATIVE WRINKLE TREATMENT HANDPIECE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NOBLUS ULTRASOUND SCANNER

FDA Adverse Event
Malfunction ·Product code IYO·March 30, 2017

STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 7, 2020

CD HORIZON BALLAST SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

CONTAK RENEWAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIK·October 1, 2014

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

PROPEX

FDA Adverse Event
Malfunction ·DENTSPLY MAILLEFER·Product code LQY·June 13, 2011

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015