Company ยท US
Ascent Healthcare Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2011. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
41recalls (0 in 12 months)
34recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 22 |
| JOW | Sleeve, Limb, Compressible | 7 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 7 |
| KCY | Tourniquet, Pneumatic | 4 |
| NLF | Oximeter, Reprocessed | 4 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 4 |
| HAB | Saw, Powered, And Accessories | 3 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 2 |
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | 2 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 2 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| NMF | Clamp, Vascular, Reprocessed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2011 | K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER Ascent Healthcare Solutions | NUJ |
| Jul 18, 2011 | K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT Ascent Healthcare Solutions | NUJ |
| Jul 23, 2010 | K100909 | REPROCESSED COMPRESSION SLEEVES Ascent Healthcare Solutions | JOW |
| May 28, 2010 | K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Ascent Healthcare Solutions | NLH |
| May 12, 2010 | K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE Ascent Healthcare Solutions | NLQ |
| Mar 19, 2010 | K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT Ascent Healthcare Solutions | NLM |
| Mar 4, 2010 | K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS Ascent Healthcare Solutions | NLQ |
| Oct 21, 2009 | K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 Ascent Healthcare Solutions | OWQ |
| Apr 1, 2009 | K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions | NLH |
| Sep 16, 2008 | K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions | NLH |
| Jul 29, 2008 | K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS Ascent Healthcare Solutions | NLF |
| Jul 9, 2008 | K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions | NLH |
| Oct 15, 2007 | K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS Ascent Healthcare Solutions | NLM |
| Oct 2, 2007 | K070059 | REPROCESSED TROCARS Ascent Healthcare Solutions | NLM |
| Aug 17, 2007 | K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES Ascent Healthcare Solutions | NQG |
| Aug 17, 2007 | K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES Ascent Healthcare Solutions | NQG |
| May 16, 2007 | K062525 | REPROCESSED LIGASURE VESSEL SEALER/DIVIDER Ascent Healthcare Solutions | GEI |
| Mar 29, 2007 | K063076 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER Ascent Healthcare Solutions | OWQ |
| Jan 31, 2007 | K062497 | REPROCESSED TROCARS Ascent Healthcare Solutions | NLM |
| Oct 11, 2006 | K053585 | VANGUARD REPROCESSED SUTURE PASSER Ascent Healthcare Solutions | NLM |
| Sep 5, 2006 | K061759 | REPROCESSED EXTERNAL FIXATION DEVICE Ascent Healthcare Solutions | KTT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland Terminated |
HRX | K012613 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot num Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot numbe Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style - Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, F Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE PLUS***Yellow/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakel Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style - Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195024***Expir Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205345***DYONICS***Arthroscopic Blade***4.5mm INCISOR PLUS, 13cm long***Fits Power/EP-1 Motor Drives***Violet***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205330***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm STONECUTTER, 13cm long***Fits Power/EP-1 Motor Drives***Maroon***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205326***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm ACROMIONIZER, 13cm long***Fits Power/EP-1 Motor Drives***Mauve***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205316***DYONICS***Arthroscopic Blade***4.5mm TURBOWHISKER, 13cm long***Fits Power/EP-1 Motor Drives***Navy Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTI Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205314***DYONICS***Arthroscopic Blade***5.5mm INCISOR, 13cm long***Fits Power/EP-1 Motor Drives***Mocha***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lak Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR, 13cm long***Fits Power/EP-1 Motor Drives***Forest Green***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTI Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS** Terminated |
HRX | K012611 K012652 |
| Aug 10, 2010 | Ascent Healthcare Solutions, Inc. ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165. Terminated |
NMF | K011832 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories. Terminated |
HAB | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K012695 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K012640 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated |
KCY | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated |
KCY | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories. Terminated |
HAB | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories. Terminated |
HAB | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories. Terminated |
NLM | K053585 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated |
KCY | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K012695 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K043198 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K012695 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic Arthroscope. Terminated |
HRX | K012695 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K012403 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve. Terminated |
JOW | K051438 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter. Terminated |
NLF | K012344 |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock Connector Brown Trim, Latex Free - Reprocessed Sterile device -- Pneumatic tourniquet. Terminated |
KCY | None listed |
| Sep 19, 2008 | Ascent Healthcare Solutions, Inc. Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. Terminated |
JOW | K012403 |
| Feb 8, 2007 | Ascent Healthcare Solutions, Inc. AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length. Terminated |
NLM | K043594 |