19 results · 22ms · Sources: EU EUDAMED, 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