29 results · 34ms · Sources: EU EUDAMED, US FDA

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Precice® Ankle Salvage System

FDA 510(k)
FDA Class 2 ·Orthopedic

KeyPrint

FDA UDI
Keystone Industries·H66842004301·KeyDenture BAse Original 0.5kg

ISOLA

FDA UDI
DEPUY SPINE, LLC·10705034006635·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 6.5mm

LAHEY FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060869·LAHEY FORCEPS RIGHT ANGLED LONGITUDINAL SERRATIONS

Accufit

FDA UDI
Ortho Organizers, Inc.·00190707183714·Accufit Molar Bands Lower Left First Molar 43

Triglyceride LiquiColor® (Mono)

FDA UDI
STANBIO LABORATORY, L.P.·00657498001035·For the Quantitative Enzymatic-Colorimetric Det...

AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT

FDA Adverse Event
Malfunction ·PERKINELMER, INC.·Product code QJR·March 5, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 4, 2023

DS2ADV AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·May 27, 2024

DREAMSTATION 2 ADV AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 3, 2025

DS2ADV AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 8, 2024

S-ROM*SLEEVE PRX ZT HA 16D-LRG

FDA Adverse Event
Injury ·9616671 DEPUY IRELAND·Product code MEH·May 10, 2013

SROM STM ST,36+6L NK,11X16X150

FDA Adverse Event
Injury ·9616671 DEPUY IRELAND·Product code MRA·May 10, 2013

DS2ADV AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·July 30, 2024

ACCU-CHEK SPIRIT

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 6, 2010

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

UNICEL® DXI 800 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 11, 2011

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 1, 2013