Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Prosthetic Heart Valve

B-BOP®

FDA UDI

NEWDEAL·10381780052944·The wedge 20° is used to adjust the orientation...

B-BOP®

FDA UDI

NEWDEAL·10381780052920·The wedge 10° is used to adjust the orientation...

ACE

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950025534·RULER INTERMAXILLARY PLASTIC *COLD STERILIZE ON...

B-BOP®

FDA UDI

NEWDEAL·10381780052937·The wedge 15° is used to adjust the orientation...

ACE

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950025541·* RULER PATIENT OPENING GAUGE (INTERINCISAL GUI...

ACE

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950025503·PROTRACTOR CEPHALOMETRIC L/F *COLD STERILIZE ONLY*

SURFIX®

FDA UDI

NEWDEAL·10381780044659·The SURFIX® distractor allows opening at the co...

BENCOX DA Instruments Hip System

FDA UDI

Corentec Co., Ltd·08800017285429·Anteversion Guide-Anterior Direction

ACE

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950025527·TEMPLATE ACE TOOTH TRACING *COLD STERILIZE ONLY*

Tank of X-free

Device

EU IVDR · Eu Ivd Class A ·Bio-Optica Milano S.p.A.·On the market·32 countries

IntraOs 70

FDA UDI

BLUO ELECTRONICS SRL·E31593202013000·Intraoral X-ray unit (70 kV, 7 mA), sensor not ...

IntraOs DG

FDA UDI

BLUO ELECTRONICS SRL·E31593250013000·Intraoral X-ray unit (70 kV, 3.5 mA), sensor no...

Vario DG

FDA UDI

BLUO ELECTRONICS SRL·E31562802700·Intraoral X-ray unit (70 kV, 3.5 mA), sensor no...

Esteya

FDA UDI

Nucletron B.V.·08717213051058·Surface Applicator, 20mm

Esteya

FDA UDI

Nucletron B.V.·08717213039162·Esteya Surface Applicator Cap XT Mini Set

Esteya

FDA UDI

Nucletron B.V.·08717213036109·Esteya Surface Applicator Cap Set

Esteya

FDA UDI

Nucletron B.V.·08717213051034·Surface Applicator, 10mm

Esteya

FDA UDI

Nucletron B.V.·08717213051027·Surface Applicator, 30mm

Esteya

FDA UDI

Nucletron B.V.·08717213057760·Esteya