14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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