13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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