27 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPIQ Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568533·CoRoent Ant TLIF Ti, 10x10x30mm 4°
ReLine
FDA UDI
Nuvasive, Inc.·00195377047359·RELINE-O Trial,8mm H Pedicle L-pop
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753513426·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006422·1.6mm Pilot Drill, Long, Osteopower
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856001817·TI ALLOY PRECONTOURED ROD 5.5DIA X 40MM
ELMED
FDA UDI
ELMED INCORPORATED·00842180175815·REPLACEMENT SEALING CAP FOR OPERATING SCOPE WIT...
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019930218·BIT, HEXALOBE 15 AO
HARDYDISK, TETRACYCLINE 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
DISPOSABLE LIGHT HANDLE AND ADAPTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 11, 2020
LIFECARE PCA PLUS INFUSER
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code MEA·July 1, 2004
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 1, 2013
CADD LEGACY 1 PUMPS - 6400
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 14, 2022
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·December 29, 2021
KIDS KIT (TM) 18" ADD-ON BLOOD SAMPLING KIT
FDA Adverse Event
Malfunction
·MEDEX·Product code CBT·September 21, 2004
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025