19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAMOND-FLEX(R) GRASPERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
RUSSELL-TAYLOR
FDA UDI
Smith & Nephew, Inc.·03596010034533·T-HANDLE JACOBS CHUCK
Utrecht Interstitial Fletcher CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213034747·Interstitial Ovoid (left) 15mm 25°, R10
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160121·
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZOLL M SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 13, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 10, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 20, 2011
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
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·April 19, 2022
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024