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The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005861 ()
D4D0192
- Basic diagnostic x-ray system application software
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution
- 00857515006160 ()
- Total Volume: 500 Milliliter
91005
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution
- 00857515006153 ()
- Total Volume: 500 Milliliter
91004
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution
- 00850391007160 ()
- 00850391007139 ()
- Bone wax, synthetic
Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution
- 00850391007153 ()
- 00850391007023 ()
- Bone wax, synthetic
Seamfree Single Syringe with Tips
Vista Dental
1
In Commercial Distribution
- 00850194007336 ()
104-01
- Dental restorative unfilled resin kit, standard
Syndex with Constrictor® Technology for Syndesmosis Repair
DUNAMIS MEDICAL, LLC
MSYN0000
In Commercial Distribution
- 00854629006727 ()
MSYN0000
- Orthopaedic fixation suture button
- Fluted surgical drill bit, single-use
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution
- 00851861007246 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution
- 00851861007222 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis
DenteShield Sample Opaque with Fluoride
ELEVATE ORAL CARE, LLC
685DSSAMP
Not in Commercial Distribution
- 00858290006598 ()
- Dental unfilled resin sealant/coating
No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution
- 20853620005207 ()
- 10853620005200 ()
- 00853620005203 ()
- Basic intravenous administration set, noninvasive
Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution
- 05707480041848 ()
- 05707480133918 ()
814320-000/50
- Polysomnograph
ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution
- 00664816001745 ()
- Microhaematocrit centrifuge IVD
No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution
- 00852184003458 ()
- Percutaneous electrical stimulation lead external pulse generator cable, reusable
DermLite Foto X with Nailio
DermLite LLC
DLFX-NL1
In Commercial Distribution
- 00855997006890 ()
DLFX-NL1
- Dermatoscope, optical
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution
- 00854763006188 ()
- Surgical ultrasound imaging transducer
PFFG-32 RA PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-32 RA
In Commercial Distribution
- 00856449006147 ()
- 10856449006144 ()
- 20856449006141 ()
- Catheter Gauge: 32 French
- Mediastinal drainage catheter, non-antimicrobial
- Pleural catheter
- Closed-wound drain, non-bioabsorbable
PFFG-28 RA PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-28 RA
In Commercial Distribution
- 20856449006127 ()
- 10856449006120 ()
- 00856449006123 ()
- Catheter Gauge: 28 French
- Closed-wound drain, non-bioabsorbable
- Mediastinal drainage catheter, non-antimicrobial
- Pleural catheter
PFFG-24 XDL PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-24 XDL
In Commercial Distribution
- 20856449006103 ()
- 10856449006106 ()
- 00856449006109 ()
- Catheter Gauge: 24 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG-32 PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-32
In Commercial Distribution
- 20856449006080 ()
- 10856449006083 ()
- 00856449006086 ()
- Catheter Gauge: 32 French
- Closed-wound drain, non-bioabsorbable
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial