Accelerate Arc System
Accelerate Diagnostics, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1911273 | 1000119345 | ACCELERATED CARE PLUS CORP. | 1 | Y | 2026-01-01 | 1170 Trademark Dr Ste 104 RENO NV US 89521 |
| 3009132612 | 3003042119 | ACCEL INC. | 1 | N | 2026-01-01 | 9000 SMITH'S MILL RD New Albany OH US 43054 |
| 2523896 | 2523896 | ACCELETRONICS, INC. | 1 | Y | 2020-04-25 | 602 GORDON DR. EXTON PA US 19341 |
| 3010671651 | 3010671651 | ACCELERATE DIAGNOSTICS, INC. | 1 | N | 2020-04-25 | 3950 S COUNTRY CLUB RD STE 470 Tucson AZ US 85714 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850074049098 | Mediwash Antimicrobial Rx Hydrogel, 237 mL - 237 mL bottle of 0.015% Hypochlorous Acid (HOCI) Hydrogel for post-operative care, management of partial & full thickness wounds, including burns. Rx Only. | 800-676-3891 | mediwash@acceleratepharm.com |
| 00850074049104 | Mediwash Antimicrobial Hydrogel, 237 mL - 237 mL bottle of 0.015% Hypochlorous Acid (HOCI) Hydrogel for post-operative care, management of partial & full thickness wounds, including burns. | 800-676-3891 | mediwash@acceleratepharm.com |
| 00850074049111 | Mediwash Antimicrobial Rx Advanced Skin & Wound Solution, 237 mL - 237 mL bottle of 0.015% Hypochlorous Acid (HOCI) skin and wound solution for cleansing and debridement. To clean acute and chronic wounds, such as surgical sites, cuts, burns, ulcers, pressure sores; removing debris, bacteria, and/or biofilm while promoting a moist healing environment. Rx Only. | 800-676-3891 | mediwash@acceleratepharm.com |
| 00850074049128 | Mediwash Antimicrobial Advanced Skin & Wound Solution, 237 mL - 237 mL bottle of 0.015% Hypochlorous Acid (HOCI) skin and wound solution for cleansing and debridement. To clean acute and chronic wounds, such as surgical sites, cuts, burns, ulcers, pressure sores; removing debris, bacteria, and/or biofilm while promoting a moist healing environment. | 800-676-3891 | mediwash@acceleratepharm.com |
| 00850074049135 | Mediwash Antimicrobial Advanced Skin & Wound Solution, 59 mL - 59 mL bottle of 0.015% Hypochlorous Acid (HOCI) skin and wound solution for cleansing and debridement. To clean acute and chronic wounds, such as surgical sites, cuts, burns, ulcers, pressure sores; removing debris, bacteria, and/or biofilm while promoting a moist healing environment. | 800-676-3891 | mediwash@acceleratepharm.com |
| 00858703006054 | Neuroprobe 500 Pro - The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Currentin bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation.Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible superluminous diodes (SLD).The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for painmanagement with trigger point stimulation for pain control.The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensorynerve block, or through the optional probe to produce local trigger point anesthesia. | 800-350-1100 | customersupport@acplus.com |
| 00858703006252 | Ultraphonic (250ml Bottle) - Ultrasound Gel | 800-350-1100 | customersupport@acplus.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 33556 | 1444676066 | K973732 | MEGAPULSE II | IMJ | 1998-01-23 |
| 33556 | 1096064736 | K945509 | FX-2 NMS (2CHANNEL TABLE MODEL) | IPF | 1995-05-02 |
| 33556 | 1231381669 | K945508 | FX-2P NMS (2 CHANNEL PORTABLE) | IPF | 1995-05-02 |
| 178421 | 1560109883 | K932291 | EUTRA GEL FOR WOUND DRESSING | MGQ | 1994-07-18 |
| 33556 | 1791353679 | K883893 | OMNISOUND(TM) 3000 | IMG | 1988-11-01 |
| 33556 | 1409902179 | K874076 | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR | IPF | 1988-01-04 |
| 33556 | 2066774722 | K850850 | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR | IPF | 1985-07-01 |
| 33556 | 1174715850 | K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | GZJ | 1983-07-18 |
| 33556 | 1695810434 | K821523 | OMNI TENS | GZJ | 1982-06-16 |
| 33556 | 1479295036 | K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | IMG | 2016-08-26 |
| 33556 | 1713219803 | K153456 | Megapulse III Shortwave Diathermy | IMJ | 2016-06-14 |
| 33556 | 1341868176 | K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | KPI | 2009-12-04 |
| 178421 | 1609809021 | K073610 | ELTA ADVANCED WOUND WASH | FRO | 2008-04-23 |
| 33556 | 1961676199 | K060191 | ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT | ILY | 2006-07-12 |
| 178421 | 1152278461 | K051481 | JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP | IOR | 2005-06-29 |
| 33556 | 1001611874 | K010543 | KM-30 TENS ELECTRODE | GXY | 2001-05-23 |
| 205399 | 1457808163 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | PRH | 2017-02-23 |
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| 178421 | 2066511568 |
Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc.
Accelerated Care Plus (ACP)
Accelerated Care Plus
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCEL SPINE
ACCELETRONICS DIGITAL IMAGING, LLC.
ACCELERATED CARE PLUS
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELERATED INNOVATION, LLC
ACCELLENT INC.
ACCELERATED CARE PLUS CORP.
ACCELERATED REHAB DESIGNS, INC.
ACCELERATED REHAB DESIGNS, INC.
ACCELERATED REHAB DESIGNS, INC.
ACCELERATOR SYSTEMS INTL., INC.
2016-08-16
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