Search Results
Found 3252 results
510(k) Data Aggregation
(28 days)
The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 8 µL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control).
N/A
Ask a specific question about this device
(87 days)
The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The Picosecond Laser Device mainly consists of a main unit, a light guide arm, a standard handpiece, a foot switch, a power cord, and other auxiliary treatment accessories.
The main unit includes power supply unit, control unit, laser system, water circulation cooling system.
Accessories include goggles, eye mask, funnel assembly, drainage nozzle, fuse tubes, remote control interlock connector, and keys.
The Picosecond Laser Device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).
N/A
Ask a specific question about this device
(27 days)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.
N/A
Ask a specific question about this device
(129 days)
The Remi Custom Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.
The Remi Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
Remi Night Guards are manufactured using impressions and/or scans.
N/A
Ask a specific question about this device
(22 days)
TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.
N/A
Ask a specific question about this device
(27 days)
The ProZip Knotless Implant is intended for use in soft-tissue approximation.
The ProZip Knotless Implant is comprised of braided ultra-high molecular weight polyethylene (UHMWPE) and Polyester sutures. It contains one working suture, also referred to as the repair strand, and shuttle strand that is used to shuttle the repair strand around the tissue. Additionally, the repair strand has a suture attached at either end to aid in passing through tissue, known as adaptor tail.
Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
N/A
Ask a specific question about this device
(15 days)
TargetCool-e (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
TargetCool-e (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
TargetCool-e is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool-e device consists of a main device, nozzle, a guard and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool-e displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.
N/A
Ask a specific question about this device
(271 days)
The Hemastyl Wound Gel is indicated for use as follows:
Hemastyl Wound Gel
Rx: Management of wounds such
- 1st degree burns and 2nd degree superficial burns
- stasis ulcers
- pressure ulcers
- diabetic ulcers
- lacerations
- abrasions
- skin tears
- surgical incision sites
- device insertion site wounds
- graft sites
- donor sites
OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.
Hemastyl™ Wound Dressing is a repeat use, amorphous hydrogel containing silver chloride (AgCl), cupric chloride (CuCl2) and ferric chloride (FeCl3) as preservatives and HA and fish collagen for use in the management of wounds.
N/A
Ask a specific question about this device
(25 days)
The Mini Superhawk Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
-
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
-
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.
-
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
-
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
-
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
-
Hip: Capsular Repair, Acetabular Labral Repair.
The Mini Superhawk Suture Anchors are anchor devices comprised of polyether ether ketone (PEEK) material that are designed for the fixation of soft tissue to bone. The subject Mini Superhawk system features one 3.75mm diameter Screw-in (start) suture anchor preloaded on an inserter with a 1.5mm suture tape and one knotless 3.75mm diameter Push-in suture anchor preloaded on an inserter with a suture pull tab. The Push-in anchor also includes an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Mini Superhawk Suture Anchors and inserters are assembled as a kit and provided to the end user sterile via ethylene oxide (EO) sterilization.
N/A
Ask a specific question about this device
(90 days)
Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers.
The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.
A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline.
A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.
In vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein (pTau181p) in human plasma.
Elecsys Phospho-Tau (181P) Plasma utilizes a sandwich test principle and has a total duration time of 18 minutes.
- 1st incubation: 30 µL of sample, biotinylated monoclonal antibody specific for phosphorylation at threonine 181, and a monoclonal tau-specific antibody labeled with a ruthenium complex^a) react to form a sandwich complex.
- 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
- The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the cobas link.
N/A
Ask a specific question about this device
Page 1 of 326