ACE Alkaline Phosphatase Reagent

FDA registration

ALFA WASSERMANN·3 products·🇺🇸 United States

Dimension Vista CO2 Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·3 products·🇺🇸 United States

BIALEX AST

FDA registration

BIALEX LAB·3 products·🇺🇸 United States

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660103118·Bores 2-ray axis marker, 4 1/8'', flat handle, ...

accessory

FDA UDI

Amann Girrbach AG·E4942186101·

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660103125·Bores 2-ray axis marker, 4'', flat handle, for ...

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660104740·Henderson Toric IOL axis marker, 4'', slim prof...

IJS

FDA UDI

SKELETAL DYNAMICS L.L.C.·00841506105239·

Paragon Z CRT Dual Axis

FDA UDI

Paragon Vision Sciences, Inc.·B22222·Paragon Z CRT Dual Axis contact lenses are manu...

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660104757·Henderson Toric IOL axis marker, 4'', slim prof...

Ambler Surgical

FDA UDI

AMBLER SURGICAL CORP.·00190660103101·Bores 2-ray axis marker, 3 7/8'', round handle,...

WayPoint™ Entry Offset Mounting Hub

FDA UDI

FHC, INC.·00873263006047·WayPoint 3mm Entry Offset Mounting Hub for use ...

WayPoint™ Target Offset Mounting Hub

FDA UDI

FHC, INC.·00873263007242·WayPoint Target Offset Mounting Hub, 6mm offset...

WayPoint™ Target Offset Mounting Hub

FDA UDI

FHC, INC.·00873263003107·WayPoint Target Offset Mounting Hub, 6mm offset...