19 results · 26ms · Sources: EU EUDAMED, US FDA

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FACTOR XI DEFICIENT PLASMA

FDA 510(k)
FDA Class 2 ·Hematology

Arthrex®

FDA UDI
ARTHREX, INC.·00888867050624·LO-PRO SCRW,TI,3.5MMX 36MM

ASTRA TOTAL PROTEIN REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

PROXIMATE ILS CIRCULAR STAPLES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

PROXIMATE ILS CIRCULAR STAPLERS

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

CASING FOR 12V BATTERY

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 25, 2014

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 6, 2015

CLINICAL CHEMISTRY PHENOBARBITAL

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJC·January 2, 2013

LOCKING SCREW, TITANIUM 3.5MM X 22MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 26MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 38MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 30MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

CALCANEAL FRAC PERIMETER PLT,XS,RT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HRS·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 24MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 34MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LO-PRO SCRW,TI,3.5MMX 36MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

LOCKING SCREW, TITANIUM 3.5MM X 28MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

FDA Enforcement
Class II ·Terminated·STERILMED, INC.·June 8, 2016