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

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LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RESTORIS

FDA UDI
MAKO SURGICAL CORP.·00848486003432·MCK PATELLOFEMORAL TRIAL (6 RIGHT)

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107408·TRIAL 90-SRK-170416 POLY UCCS 4X16MM

ABL835 FLEX ANALYZER WITH PLEURAL PH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP

FDA 510(k)
FDA Class 2 ·Anesthesiology

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 20, 2011

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 14, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

EQUINOXE COMPRESSION SCREW

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 27, 2025

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018