13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SHEATHES STERILE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925011939·AUSTIN PICK 90 DEGREE TIP ANGLE 1.10 MM TIP LEN...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003148·Left L Plate, 6mm, Rigid
TISSUE FORCEPS ADSON 4 3/4"-1x2 TEETH
FDA UDI
W.H. Holden, Inc.·D9281300410·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186770·
Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse Oximeter
FDA UDI
VASOMEDICAL, INC.·00817980021440·EZ™ Software CD and Data Cable for Wrist Pulse ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197044233·Gerald Dressing Forceps
bayone...
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARE SU01A SUCTION ASPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISIONAIRE V
FDA Adverse Event
Other
·AIRSEP CORP.·Product code CAW·May 22, 2013
PFC SIGMARP STB TB IN 3 10.0
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·September 30, 2014
MAESTRO DRILL WITH HANDSWITCH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·May 5, 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