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 Tijuana, B.C. C.P. Baja California, Mexico, 127 510(k) clearances
ICU Medical Healthcare Manufacturing S.A. de C.V. is registered with the FDA (registration 9617604) in Tijuana, B.C. C.P. Baja California, Mexico. It lists 58 device types. The FDA files 127 510(k) clearances under its listings, the newest dated November 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617604
- FEI number
- 3002558692
- Address
- AVENIDA CALIDAD No 14409 Parque Industrial Internacional Tijuana, Tijuana, B.C. C.P. Baja California, Mexico, 22424
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 20, 1992
- Registered through
- 2026
- Brand names listed
- "SNUGGLE WARM" CONVE, 1st Response Adult Manual Resuscita, 250 ML Reservoir with FFP, ANALYZER, ANESTHESIA BREATHING CIRCUITS, Adapter, Administration Set Male/Male Luer, Anesthesia Breathing Bag 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. Newest 100 of 127.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 26, 2021 | K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 18, 2020 | K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets | FPA | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 12, 2018 | K172823 | Portex NRFit Epidural Needles | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 1, 2018 | K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 8, 2018 | K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| 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 |
| December 7, 2017 | K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 20, 2017 | K162219 | CADD® Infusion Disposables Portfolio with NRFit connectors | PWH | 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 |
| August 2, 2012 | K121525 | PERIFUSE CATHETER | CAZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| February 9, 2012 | K112407 | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS | DYB | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| August 3, 2010 | K101180 | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| March 1, 2010 | K093414 | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS | LJT | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| November 4, 2009 | K092657 | EPIFUSE CATHETER CONNECTOR, MODEL: 4909E | CAZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 18, 2009 | K083031 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | BTO | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 3, 2009 | K083336 | LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL | DWJ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 1, 2009 | K090261 | PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G | BSP | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| March 4, 2009 | K083451 | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | BSN | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| February 23, 2009 | K083641 | BIVONA TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| September 12, 2008 | K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 13, 2008 | K081086 | PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 | BTR | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 21, 2008 | K081229 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING | JKA | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081156 | CADD MEDICATION CASSETTE RESERVOIR | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| June 2, 2008 | K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, | LGZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | LJT | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| November 1, 2007 | K072059 | GRIPPER MICRO NEEDLE | FMI | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| May 23, 2007 | K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE | LJT | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| October 18, 2006 | K062005 | PORTEX EPIDURAL CATHETER | BSO | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061513 | LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET | DWJ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060945 | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | BTO | Substantially Equivalent | Smiths Medical International | accessdata.fda.gov |
| November 17, 2005 | K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| July 7, 2005 | K051524 | LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 | BSO | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 26, 2005 | K050166 | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | BWC | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| October 7, 2004 | K042172 | CLEO 90 INFUSION SET | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| July 13, 2004 | K041348 | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA | JOH | Substantially Equivalent | Smiths Medical | accessdata.fda.gov |
| May 27, 2004 | K031738 | SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER | LZG | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| May 13, 2004 | K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | CAH | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| April 27, 2004 | K040632 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 | DWJ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| February 13, 2004 | K040014 | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY | JOH | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| January 26, 2004 | K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) | BTR | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| November 28, 2003 | K032716 | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) | CAH | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| September 17, 2003 | K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| August 27, 2003 | K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | BTO | Substantially Equivalent | Portex , Ltd. | accessdata.fda.gov |
| May 23, 2003 | K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP | FPA | Substantially Equivalent | Deltec, Inc. | accessdata.fda.gov |
| August 13, 2002 | K021999 | GRIPPER PLUS NEEDLE | FPA | Substantially Equivalent | Deltec, Inc. | accessdata.fda.gov |
| February 27, 2002 | K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | BTM | Substantially Equivalent | Portex, Inc. | accessdata.fda.gov |
| December 18, 2001 | K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM | DWJ | Substantially Equivalent | Sims Level 1, Inc. | accessdata.fda.gov |
| March 8, 2001 | K010426 | PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| December 14, 2000 | K002506 | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT | CAH | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
| August 9, 2000 | K001764 | HOTLINE 2 FLUID WARMER | LGZ | Substantially Equivalent | Sims Level 1, Inc. | accessdata.fda.gov |
| April 28, 2000 | K993619 | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | BSP | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
| April 27, 2000 | K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| January 27, 2000 | K994216 | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| October 22, 1999 | K992471 | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 | BSO | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
| June 15, 1999 | K991599 | CADD ADMINISTRATION SET | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| February 12, 1999 | K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| January 29, 1999 | K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | MIA | Substantially Equivalent | Sims Portex, Inc. | accessdata.fda.gov |
| January 22, 1998 | K974471 | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| December 17, 1997 | K974013 | EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 13, 1997 | K970785 | SIMS HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | Sims | accessdata.fda.gov |
| March 14, 1997 | K965017 | REGIONAL ANESTHESIA TRAYS | CAZ | Unknown | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| January 17, 1997 | K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| December 17, 1996 | K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | CAP | Substantially Equivalent | Intertech Resources, Inc. | accessdata.fda.gov |
| October 1, 1996 | K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| September 20, 1996 | K961580 | PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| February 12, 1996 | K955407 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS | LJT | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| November 20, 1995 | K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | CBT | Substantially Equivalent | Devon Industries, Inc. | accessdata.fda.gov |
| October 24, 1995 | K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | CBI | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| July 31, 1995 | K951078 | CATHETER, INTRAVASCULAR OR PERCUTANEOUS | LJS | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| July 10, 1995 | K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | FMI | Substantially Equivalent | Devon Industries, Inc. | accessdata.fda.gov |
| June 8, 1995 | K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | Intertech Resources, Inc. | accessdata.fda.gov |
| June 8, 1995 | K952062 | PFT FILTER | CAH | Substantially Equivalent | Intertech Resources, Inc. | accessdata.fda.gov |
| February 21, 1995 | K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | MEA | Substantially Equivalent - Subject to Tracking Reg. | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| October 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 4, 1994 | K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE | FPA | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| July 26, 1994 | K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | LJT | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| May 5, 1994 | K931073 | CATH-FINDER | FOZ | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| February 9, 1994 | K933390 | REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG | FPA | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| January 14, 1994 | K934465 | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE | BTR | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| January 5, 1994 | K932841 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS | LJT | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| January 5, 1994 | K932840 | PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| January 5, 1994 | K932095 | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S | LJT | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| October 25, 1993 | K923559 | STERI-CATH MDI | CAF | Substantially Equivalent | Concord/Portex | accessdata.fda.gov |
| July 1, 1993 | K930816 | HEPA FILTERED HME | CAH | Substantially Equivalent | Intertech Resources, Inc. | accessdata.fda.gov |
| May 18, 1993 | K931735 | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE | BTR | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| December 29, 1992 | K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| September 11, 1992 | K920469 | MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE | FLL | Substantially Equivalent | Respiratory Support Products, Inc. | accessdata.fda.gov |
| September 1, 1992 | K923090 | SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD | JKA | Substantially Equivalent | Ryan Medical, Inc. | accessdata.fda.gov |
| January 30, 1992 | K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 23, 1991 | K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 17, 1991 | K911383 | HOTLINE FLUID WARMER | LGZ | Substantially Equivalent | Level 1 Technologies, Inc. | accessdata.fda.gov |
| August 9, 1991 | K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| July 17, 1991 | K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| June 19, 1991 | K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| April 17, 1991 | K910509 | PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 | CCK | Substantially Equivalent | Intertech Resources, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated November 26, 2021. 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.