44 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
Bur PM2-70 50K Diam Ø4.5
FDA UDI
Bien-Air Surgery SA·07630055502339·
ARGENCO Y+
FDA UDI
ARGEN CORPORATION, THE·D818100257·Gold based noble metal
COOLEY RENAL ARTERY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921002570·COOLEY RENAL ARTERY CLAMP ANGLED
BD VACUTAINER EDTA 2K
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 11, 2020
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZOLL M SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
microTargeting™ Electrode Cable
FDA UDI
FHC, INC.·00873263002575·microTargeting Electrode Cable w/ Alligator Cli...
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 28, 2024
MESH, SURGICAL, POLYMERIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 12, 2015
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 6, 2016
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 4, 2015