22 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEHC DXA Bone Densitometers with enCORE version 18
FDA 510(k)
FDA Class 2
·Radiology
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331184062·Jeweler's Bipolar Forceps, 0.4 mm tip, 4" (10.0...
Orthos
FDA UDI
ORMCO CORPORATION·00889989029925·ORTHOS CM SST ARCH 019X025 LOSM PK10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198901·AK3 Congruent Insert Trial Size 1, 12mm
VIDAS® CMV IGG ASSAY
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LFZ·August 2, 2019
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586G19111225INS0·jeweler forcep, insulated, non-stick, straight ...
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESPIRONICS SLEEPEASY CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191112801·IN-OVATION® mini EURO 022/UR1 17T 4A
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107569·TRIAL 90-SRK-191112 POLY-MPCS 1X12 RIGHT
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719111200R1·IN-OVATION® mini Rhodium Base Rx 022/UR1 12T 5A
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191112001·IN-OVATION® mini Base Rx 022/UR1 12T 5A
VIDAS® CMV IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LKQ·March 11, 2019
VIDAS® CMV IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LKQ·June 16, 2019
VIDAS® CMV IGG ASSAY
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LFZ·September 5, 2019
CORAIL2 NON COL HO SIZE 9
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWA·June 26, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 25, 2011
J-VAC RESERVOIR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GCY·September 26, 2008
SINGLE USE GUIDWIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code OCY·April 21, 2020
REVISION MOD. STEM Ø24MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·October 21, 2022