Company ยท US
Ecolab Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2019. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2019 | K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand Ecolab, Inc. | NHV |
| Jun 29, 2018 | K173164 | Ecolab POU Water Filter Ecolab, Inc. | NHV |
| Jan 15, 2016 | K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes Ecolab, Inc. | LHC |
| Feb 26, 2015 | K150190 | IntraTemp Solution Warmer Ecolab, Inc. | LHC |
| Dec 30, 2014 | K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE Ecolab, Inc. | LHC |
| Aug 28, 2014 | K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED Ecolab, Inc. | LHC |
| Sep 30, 1988 | K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY Ecolab, Inc. | CAE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Ecolab Inc Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solut Terminated |
PUI | None listed |
| Sep 14, 2018 | Ecolab Inc Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Terminated |
PUI | None listed |
| Sep 14, 2018 | Ecolab Inc Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Terminated |
PUI | None listed |
| Sep 14, 2018 | Ecolab Inc Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical
Prod Terminated |
PUI | None listed |
| Sep 14, 2018 | Ecolab Inc Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical
Pro Terminated |
PUI | None listed |
| Nov 22, 2017 | ECOLAB INC ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX.
To be used as a physical barrier Terminated |
IYO | K961029 |
| Nov 22, 2017 | ECOLAB INC ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX.
To be used as a physical barrie Terminated |
IYO | K961029 |
| Oct 13, 2017 | Ecolab, Inc. Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a Terminated |
FTA | None listed |
| Nov 30, 2016 | Ecolab Inc Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. Terminated |
KKX | K882724 |
| Jul 14, 2016 | Ecolab Inc Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, Terminated |
KKX | None listed |
| Sep 18, 2015 | Ecolab Inc Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331
and ORS-2200.
The ORS Fluid Warming and Terminated |
LHC | K021288 K023282 +1 |
| Feb 10, 2014 | Ecolab Inc Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois Terminated |
KKX | K882724 |
| Feb 10, 2014 | Ecolab Inc MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Terminated |
KKX | K882724 |
| Feb 10, 2014 | Ecolab Inc MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Terminated |
KKX | K882724 |
| Feb 10, 2014 | Ecolab Inc MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Terminated |
KKX | K882724 |
| Feb 10, 2014 | Ecolab Inc MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Terminated |
KKX | K882724 |
| Feb 10, 2014 | Ecolab Inc MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702. Terminated |
KKX | K882724 |