34 results · 21ms · Sources: EU EUDAMED, 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