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

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Slit Lamp Microscope

FDA 510(k)
FDA Class 2 ·Ophthalmic

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·G586G1524290·ragnell (kilner) scissors, curved, 7" (17.8 cm)

1.5 LACTOSORB SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036055691·

CORONIS 3MP-21 AND MFGD 3621

FDA 510(k)
FDA Class 2 ·Radiology

ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

O3 PEDIATRIC SENSOR

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

O3 PEDIATRIC SENSOR

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·June 7, 2013

PLUM XLD 110V L.A.

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 3, 2014

HS II PROXIMAL SEAL SYSTEM 4.3MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·June 24, 2011

SCREWDRIVER BIT T15, AO FITTING

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

SCREWDRIVER BIT T15, AO FITTING

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024