17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
N/A
FDA UDI
Tyber Medical, LLC·M695M1302160·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776306458·Tissue Forceps 5 12" 4x5 teeth
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450723104·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180586·Integra® Jarit® Tissue Forceps, 5-3/4", 4 x 5 T...
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
ENDO GIA ROTICULATOR 60-3.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·April 8, 2013
COLONCARE
FDA 510(k)
FDA Class 2
·Hematology
EXPEDIUM SYSTEM, VIPER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 24, 2013
PINNACLE MTL INS NEUT44IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 30, 2014
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·June 16, 2011
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
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