Data / Medical devices / Mexico / ICU Medical Healthcare Manufacturing S.A. de C.V.
ICU Medical Healthcare Manufacturing S.A. de C.V.: FDA-registered device maker in APODACA Nuevo Leon, Mexico, 44 510(k) clearances
ICU Medical Healthcare Manufacturing S.A. de C.V. is registered with the FDA (registration 9616567) in APODACA Nuevo Leon, Mexico. It lists 51 device types. The FDA files 44 510(k) clearances under its listings, the newest dated April 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616567
- FEI number
- 3002963732
- Address
- Carretera Miguel Aleman, KM21.7 Parque Industrial Monterrey, APODACA Nuevo Leon, Mexico, 66603
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- October 2, 1992
- Registered through
- 2026
- Brand names listed
- "SNUGGLE WARM" CONVE, AIREASY, Adapter, Aerogard, Aeromist, AquinOx, BIVONA, Berman and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2018 | K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | BTO | Substantially Equivalent | Smiths Medical Ads, Inc. | accessdata.fda.gov |
| January 25, 2018 | K171968 | EchoGlo Needle | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| November 9, 2017 | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | DRS | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 24, 2017 | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | DRS | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 30, 2016 | K160235 | ViaValve Safety I.V. Catheter | FOZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| October 28, 2014 | K141686 | EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY | DWJ | Substantially Equivalent | Smith Medical Asd, Inc. | accessdata.fda.gov |
| September 16, 2013 | K123957 | PNEUPAC PARAPAC PLUS | BTL | Substantially Equivalent | Smiths Medical International , Ltd. | accessdata.fda.gov |
| August 2, 2007 | K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 1, 2007 | K071269 | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | CBT | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| March 15, 2007 | K070340 | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | CBT | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 20, 2002 | K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | GWM | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| December 18, 2001 | K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM | DWJ | Substantially Equivalent | Sims Level 1, Inc. | accessdata.fda.gov |
| July 12, 2001 | K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO | FMI | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
| September 18, 2000 | K993282 | IPI HUMIDIFIER CHAMBER | BTT | Substantially Equivalent | I.P.I. Medical Products | accessdata.fda.gov |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
| July 21, 1998 | K982123 | CONTRAST CONTROL DEVICE | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| June 27, 1996 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 22, 1996 | K954970 | STOPCOCK & LUER LOCK PLUG | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| September 21, 1995 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| July 6, 1995 | K951805 | PIPER, MODEL NUMBER UDS-PIPERB | FEN | Substantially Equivalent | Laborie Medical Technologies, Ltd. | accessdata.fda.gov |
| February 10, 1995 | K943897 | NU-SITE | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| December 13, 1994 | K944208 | IV ADMINISTRATION SET FPA | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| August 16, 1994 | K942377 | TRANSTAR PRESSURE TRANSDUCER | DPT | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 29, 1993 | K923127 | NEEDLE-PRO CARTRIDGE | FMI | Substantially Equivalent | Concord/Portex | accessdata.fda.gov |
| August 12, 1992 | K922445 | VACU-PRO | JKA | Substantially Equivalent | Concord/Portex | accessdata.fda.gov |
| October 17, 1991 | K911383 | HOTLINE FLUID WARMER | LGZ | Substantially Equivalent | Level 1 Technologies, Inc. | accessdata.fda.gov |
| September 11, 1991 | K912709 | MX 339 TWIN HEMOSTATIC Y CONNECTOR | DTL | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| December 27, 1990 | K904674 | CENTRAL VENOUS PRESSURE MANOMETER | KRK | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| September 10, 1990 | K901315 | AEROMIST II NEBULIZER | CAF | Substantially Equivalent | Inhalation Plastics | accessdata.fda.gov |
| April 9, 1986 | K860803 | IV FILTER EXTENSION SET | FPB | Substantially Equivalent | Med Fusion Systems, Inc. | accessdata.fda.gov |
| June 5, 1984 | K841882 | THREE WAY INFUSION SET | FPA | Substantially Equivalent | Med Fusion Systems, Inc. | accessdata.fda.gov |
| November 28, 1983 | K833327 | RESPIRONICS PR VALVE | BSK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 28, 1983 | K833189 | HYDROFLOW SUCTION IRRIGATION SYSTEM | GCJ | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
| April 28, 1983 | K831087 | MINI-VOL EXTENSION SET | FPA | Substantially Equivalent | Beech Medical, Inc. | accessdata.fda.gov |
| March 8, 1983 | K830352 | REINFORCED SILICONE TRACHEAL TUBE | BTR | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
| February 9, 1983 | K830152 | MINILOOP I.V. CONNECTORS & ADAPTOR | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| March 4, 1982 | K820355 | DISPOSABLE DIAPHRAGM DOMES | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| December 20, 1979 | K792510 | MICROBAR MONITORING LINE FILTER | FPB | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| May 16, 1979 | K790407 | MICROTEC BACTERIAL FILTER | DRS | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 30, 1979 | K790408 | T-CONNECTOR | FPA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| March 23, 1979 | K790455 | MICROFLUSH | KRA | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| March 6, 1979 | K790314 | FLUID ADMINISTRATION SETS, 15 MICRON | FPB | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 22, 1979 | K782168 | 3-WAY STOPCOCK | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| February 21, 1979 | K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR | BTR | Substantially Equivalent | Respiratory Support Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Set, Administration, Intravascular
- All makers of Device, Fixation, Tracheal Tube
- All makers of Arterial Blood Sampling Kit
- All makers of Tubing, Fluid Delivery
- All makers of Catheter, Cholangiography
Updated April 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.