20 results · 21ms · Sources: EU EUDAMED, US FDA

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Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII

SURGISTAR

FDA UDI
SURGISTAR, INC.·00878799006684·

ArgenZ Anterior 95x18 #5

FDA UDI
ARGEN CORPORATION, THE·D818121277·Dental porcelain/ceramic restoration kit

CRYO.S

FDA UDI
Greiner Bio - One GmbH·14039943000030·

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032072·Speer Pack

Ambler Surgical

FDA UDI
AMBLER SURGICAL CORP.·10190660198531·Anterior chamber rycroft cannula, 30 gauge x 7....

CRYO.S

FDA UDI
Greiner Bio - One GmbH·14039943001693·

ORION II (HEAVY DUTY 350 LBS AND 500 LBS)

FDA 510(k)
FDA Class 1 ·Physical Medicine

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

FDA 510(k)
FDA Class 2 ·Microbiology

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

ZEPHYR XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC CRMD·Product code DXY·January 13, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 13, 2011

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

FDA Enforcement
Class II ·Terminated·Isopure Corp·September 21, 2022