20 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURESIGNS VS3, SURESIGNS VS4
FDA 510(k)
FDA Class 2
·Cardiovascular
Ambler Value Line
FDA UDI
AMBLER SURGICAL CORP.·00190660212797·Weil-Blakesley sinus forceps, 7'', working leng...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453000163·PENNINGTON clamp, Ø10mm, WL 330mm, double actio...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453006233·PENNINGTON clamp, Ø10mm, WL 330mm, double actio...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453022165·PENNINGTON clamp, Ø10mm, WL 330mm, double actio...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453002211·PENNINGTON clamp, Ø10mm, WL 330mm, double actio...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453022035·Insert, PENNINGTON clamp, Ø10mm,WL 330mm, doubl...
Hermann Medizintechnik GmbH
FDA UDI
Hermann Medizintechnik GmbH·04059453022325·PENNINGTON clamp, Ø10mm, WL 330mm, double actio...
SENTREX BIOSPONGE MPD
FDA 510(k)
FDA Unclassified
·Unknown
ALTIUS OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014
AEQUALIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code KWS·May 23, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 20, 2011
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER (ISRAEL) LTD.·Product code DQK·December 22, 2016
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·January 10, 2024
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