9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEINE BETA 200(R) OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TIGERPAW SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK PRIMARY CEMENTED PS FEMUR SIZE 3 RIGHT., NARROW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2015
S-ROM*SLEEVE PRX ZTT, 18D-LRG
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code LPH·May 29, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·August 21, 2008
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020
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