34 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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NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033000·Baltic Denture System BDLoad Mw7 PLSEbim6DFm C3...
Donaldson
FDA UDI
MEDTRONIC XOMED, INC.·00681490030526·VENT TUBE 1033000 ACTIVENT 5PK DONALDSON
Neutral Density Densitometer Control for SPIFE 4000
FDA UDI
HELENA LABORATORIES CORPORATION·M52510330000·
CAPTURING ROD, GALILEO® LAG SCREW
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036473·
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
FDA Recall
Terminated
·Accuray Incorporated·Product code IYE·April 10, 2018
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·June 12, 2019
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130001·PLATE BENDER, UNIVERSAL
Aladin2
FDA UDI
DATEX-OHMEDA INC·00840682100236·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702280630·Elvarex 3/Chap Style/Slant, Open Toe, E-Version...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993019144·ELVAREX 1/BODY BAND WITHOUT LEG EXTENSION/SLIP...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993319237·ELVAREX SOFT 1/KNEE HIGH/SLANT-CLOSED TOE-ELEPH...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702248814·Elvarex 2/Thigh High/Closed Toe-Elephantiasis-V...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993360949·ELVAREX SOFT 2/KNEE HIGH/SLANT-CLOSED TOE-ELEPH...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993016556·E2/BB-WOE/BS-TC-WN/FFM
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702264272·Elvarex 2/Knee High/Slant-Closed Toe-Elephantia...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702284737·Elvarex 3/Knee High/Slant-Closed Toe-Elephantia...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993355198·ELVAREX SOFT 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPH...
PEDICAP
FDA Adverse Event
Malfunction
·NELLCOR·Product code CCK·June 5, 2012