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Laser Speckle Imaging System (RFLSI CZW)

FDA 510(k)
FDA Class 2 ·Cardiovascular

SIMPLYGO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CZW·May 16, 2024

COMPLEMENT C3

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code CZW·June 5, 2019

TINA-QUANT COMPLEMENT C3C TEST SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CZW·February 22, 2024

C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code CZW·May 16, 2018

Complement C3, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Complement C3, Antigen, Antiserum, Control

BREEZE C MODEL C (3W), BREEZE C (4W)

FDA 510(k)
FDA Class 2 ·Physical Medicine

CCW

FDA UDI
Qinhuangdao Taizhi Medical Technology Co., Ltd.·06973274100520·The Disposable surgical mask (non sterile) is s...

CCW

FDA UDI
Qinhuangdao Taizhi Medical Technology Co., Ltd.·06973274100537·The mask materials include four layers, the inn...

CAW 3000

FDA UDI
Nouvag AG·ENOU5010NOU0·Contra angle for surgery wires CAW 3000

DEPUY CMW

FDA registration
DEPUY CMW·18 products·🇬🇧 United Kingdom

WASE WERKPLAATS VZW

FDA registration
WASE WERKPLAATS VZW·1 product·🇧🇪 Belgium

QardioArm

FDA UDI
QARDIO, INC.·00854894005104·

Western/Scott Fetzer

FDA UDI
Western Enterprises·B929BZW19550·SP "E" SZ MNS-603 w/WHITE CYL

Alira Medical Devices

FDA UDI
Alira Medical Devices, LLC·G767CBW1010·Cervical Bone Waxer | 216mm

C.W. Mathews - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588150604·C.W. Mathews - 18 Metal

OPTIMAT (AFDELING HUIZE TORDALE VZW)

FDA registration
OPTIMAT (AFDELING HUIZE TORDALE VZW)·1 product·🇧🇪 Belgium

Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W

FDA UDI
SPECTRUM MEDICAL SRL·18051160302267·

Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W

FDA UDI
SPECTRUM MEDICAL SRL·18051160302274·

Intacs Corneal Separator, CCW, 0.9mm

FDA UDI
ADDITION TECHNOLOGY, INC.·00850048576018·The Corneal Separators are composed of a stainl...