ClearanceBrief
Panels › Cardiovascular › Product code JOW · Class 2

Sleeve, Limb, Compressible

Regulation 870.5800

8510(k)s in 12 months (354 all time)
0recalls in 12 months (32 all time)
30recalls that name a 510(k)
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Top companies in JOW

DateFirm and productCodeLinked 510(k)
Jun 6, 2025Cardinal Health 200, LLC
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Completed
JOWK230028
Jun 6, 2025Cardinal Health 200, LLC
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Completed
JOWK230028
Jun 6, 2025Cardinal Health 200, LLC
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Completed
JOWK230028
May 19, 2023Stryker Sustainability Solutions
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Open, Classified
JOWK100909
Jul 9, 2021Ortho8, Inc.
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Open, Classified
JOWNone listed
Jul 9, 2021Ortho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Open, Classified
JOWNone listed
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Terminated
JOWK974393
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Terminated
JOWK974393
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Terminated
JOWK974393
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Terminated
JOWK974393
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Terminated
JOWK974393
Apr 8, 2019Compass Health Brands (Corporate Office)
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Terminated
JOWK974393
Feb 15, 2019COVIDIEN LLC
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Terminated
JOWK781357
Jan 17, 2019DJO, LLC
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Open, Classified
JOWK964238
Dec 1, 2017Stryker Sustainability Solutions
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and
Terminated
JOWK012403
Jun 26, 2017Arjo, Inc. dba ArjoHuntleigh
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribe
Terminated
JOWK143438
Jul 3, 2013DJO, LLC
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
Terminated
JOWK091700
Jul 1, 2013Surgical Instrument Service And Savings, Inc.
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compres
Terminated
JOWK012658
Feb 20, 2013Stryker Sustainability Solutions
STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
Terminated
JOWK090308
Dec 27, 2012Arjo, Inc. dba ArjoHuntleigh
Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence
Terminated
JOWK010744
Jan 11, 2012Medical Compression Systems
ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound
Terminated
JOWK023573
Jan 11, 2012Medical Compression Systems
ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing woun
Terminated
JOWK060146
Nov 14, 2011Albahealth LLC
Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.
Terminated
JOWK961405
Oct 1, 2010Covidien LP
AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067
Terminated
JOWK951683
Oct 1, 2010Covidien LP
AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066
Terminated
JOWK951683
Jan 13, 2009Sterilmed Inc
Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is a
Terminated
JOWK003857
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve.
Terminated
JOWK012403
Sep 19, 2008Ascent Healthcare Solutions, Inc.
VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve.
Terminated
JOWK012403
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve.
Terminated
JOWK012403
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device -- Compressible limb sleeve.
Terminated
JOWK012403
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb sleeve.
Terminated
JOWK051438
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures.
Terminated
JOWK012403

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