24 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RetCam Envision
FDA 510(k)
FDA Class 2
·Ophthalmic
JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE)
FDA UDI
JMS SINGAPORE PTE LTD·08888483005161·A.V.FISTULA 15GX1" BE 15CM W/CLAMP (SINGLE TYPE)
Cover-Roll®
FDA UDI
BSN medical GmbH·04042809021011·COVERROLL 10CM X 9.2M WHITE 1
6PW - CPRotector® TWO Economy - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White
Monster Screw System
FDA UDI
Paragon 28, Inc.·00889795016362·3.5mm Mini Monster Tap
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702870237·ELVAREX 1/THIGH HIGH/SLANT-CLOSED TOE/DOTTED SI...
UNKNOWN COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·November 21, 2021
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
FDA 510(k)
FDA Class 2
·General Hospital
REBSTOCK YASARGIL ANEURYSM CLIP
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2024
LUER SLIP TIP SYRINGE STERILE, SINGLE USE, 1 ML
FDA Adverse Event
Malfunction
·BECTON-DICKINSON AND COMPANY·Product code FRN·March 24, 2023
BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 20, 2023
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·October 17, 2008
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
STERRAD 50 STERILIZATION SYSTEM
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 2, 2013
PINN SECTOR HA ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 4, 2016
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·March 4, 2016
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·March 4, 2016
CORAIL AMT COLLAR SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575·Product code KWA·March 4, 2016
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021