18 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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FLASH BITE
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574855·CoRoent Ant TLIF Ti, 13x13x40mm 0°
DreamWear Full
FDA UDI
Respironics, Inc.·00606959045897·DreamWear Full Mask with Medium Frame, with Hea...
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138104549·NEOPRENE THUMB SPICA, UNIV
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E89611334000·Scissors, LA GRANGE SuperCut
11,5cm...
WESTCOTT TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014541·WESTCOTT TENOTOMY SCISSORS CURVED BLUNT BLADES
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702930511·ELVAREX FORTE 3/KNEE HIGH/CLOSED TOE-ELEPHANTIA...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702251623·Elvarex 2/Thigh High/Profile, Slant, Closed Toe...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702595857·E2/AD/CT/SFT/BLU
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
FDA 510(k)
FDA Class 2
·Neurology
SENO ADVANTAGE
FDA 510(k)
FDA Class 2
·Radiology
ROCCIA
FDA UDI
Silony Medical GmbH·04054896028774·ROCCIA MultiLIF Cage 13x34 mm, 0° Lor.
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 29, 2013
UNKNOWN DEPUY CEMENT
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·June 13, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·September 25, 2015
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
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