Data / Medical devices / Mexico / Arrow Internacional de Chihuahua S.A. de C.V.
Arrow Internacional de Chihuahua S.A. de C.V.: FDA-registered device maker in Chihuahua, Mexico, 226 510(k) clearances
Arrow Internacional de Chihuahua S.A. de C.V. is registered with the FDA (registration 9680794) in Chihuahua, Mexico. It lists 113 device types. The FDA files 226 510(k) clearances under its listings, the newest dated March 14, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9680794
- FEI number
- 3003737899
- Address
- Ave. Washington 3701, Interior Circuito Industrial Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana, Chihuahua, Mexico, CP 31200
- Owner or operator
- Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 2, 1995
- Registered through
- 2026
- Brand names listed
- - Arrow PICC Powered by Arrow VPS Stylet, .9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe, 0.9% SODIUM CHLORIDE FLISH SYRINGE, 14 Fr 2-L Hemodialysis Catheters, 2 LUMEN/PSI KIT, 2- Lumen PICC Products w/ Blue Flex, 2-L MAC KIT, 2-Lumen Central Venous Access (MAC) 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 226.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 14, 2025 | K243599 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | FOZ | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| December 20, 2024 | K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | FOZ | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| September 18, 2024 | K241784 | Arrow® Nitinol Wire | DQX | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| July 25, 2023 | K231924 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| February 13, 2023 | K222341 | Arrow 0.2 Micron Flat Filter, GVS | CAZ | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| September 2, 2022 | K213855 | Arrow Pressure Injectable Midline Catheter | PND | Substantially Equivalent | Arrow International, LLC Subsidiary of Teleflex Incorporated | accessdata.fda.gov |
| August 30, 2022 | K220280 | Arrow Stiffening Stylet | DRB | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| August 22, 2022 | K220363 | VPS Rhythm DLX Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| April 9, 2020 | K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| December 21, 2017 | K171109 | Praxiject 0.9% NaCl | NGT | Substantially Equivalent | Medxl, Inc. | accessdata.fda.gov |
| June 23, 2017 | K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | DQY | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | accessdata.fda.gov |
| March 17, 2017 | K162522 | UltraCath Continuous Nerve block Catheter | BSO | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 24, 2017 | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| December 22, 2016 | K160925 | VPS Rhythm Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| October 4, 2016 | K161075 | Arrow Epidural Catheter Kit | CAZ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| September 6, 2016 | K161765 | CG+ Arrow JACC | LJS | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex | accessdata.fda.gov |
| August 24, 2016 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | PND | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| July 5, 2016 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| June 21, 2016 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| June 13, 2016 | K160018 | Arrow Quickflash Arterial Catheterization Device | DQX | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| May 27, 2016 | K161170 | BD Eclipse Hypodermic Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 4, 2016 | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 4, 2016 | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | LJS | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| January 28, 2016 | K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | LJS | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| November 23, 2015 | K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 24, 2015 | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | NIE | Unknown | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| July 8, 2015 | K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | FOZ | Substantially Equivalent | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| June 5, 2015 | K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology | FOZ | Substantially Equivalent | Arrow International (A Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| March 27, 2015 | K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142393 | PREDICATE III GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| October 31, 2014 | K141126 | UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE | BSP | Substantially Equivalent | Unisis Corp. | accessdata.fda.gov |
| July 25, 2014 | K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 8, 2014 | K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS | OBJ | Substantially Equivalent | Arrow International, Inc (Subsidiary of Teleflex I | accessdata.fda.gov |
| July 7, 2014 | K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU | MSD | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 12, 2014 | K133280 | TERUMO SURFLO I.V. CATHETER | FOZ | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| March 27, 2014 | K140485 | MANDREL GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| September 26, 2013 | K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | OBJ | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| May 10, 2013 | K130192 | NEXTSTEP RETROGRADE | MSD | Unknown | Arrow International, Inc. | accessdata.fda.gov |
| April 26, 2013 | K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| January 18, 2013 | K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| January 4, 2013 | K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | DYB | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| January 3, 2013 | K123759 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Teleflex | accessdata.fda.gov |
| November 29, 2012 | K121501 | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| September 20, 2012 | K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| September 7, 2012 | K121941 | ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| August 28, 2012 | K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| August 21, 2012 | K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | QSY | Substantially Equivalent | Hemcon Medical Technologies Europe, Ltd. | accessdata.fda.gov |
| July 12, 2012 | K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE | NGT | Substantially Equivalent | Am USA | accessdata.fda.gov |
| June 21, 2012 | K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 20, 2012 | K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 16, 2012 | K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 10, 2012 | K112896 | ARRW EVOLUTION | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
| November 18, 2011 | K112554 | TRANSRADIAL ARTERY ACCESS DEVICES | DYB | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| August 17, 2011 | K111900 | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | MSD | Unknown | Teleflexmedical, Inc. | accessdata.fda.gov |
| July 29, 2011 | K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | NGT | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| June 30, 2011 | K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... | MSD | Unknown | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 18, 2011 | K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| February 1, 2011 | K102238 | ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 20, 2010 | K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| August 27, 2010 | K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 19, 2010 | K100209 | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY | FMI | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 18, 2009 | K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| March 30, 2009 | K083784 | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| December 9, 2008 | K082297 | BUSSE SURGICAL DRAPE | KKX | Substantially Equivalent | Busse Hospital Disposables, Inc. | accessdata.fda.gov |
| November 28, 2008 | K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | FMF | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| September 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 17, 2008 | K081446 | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 | BSP | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 27, 2008 | K080604 | PRESSURE INJFECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 9, 2008 | K080684 | WG-SURGICAL SUTURES WITH NEEDLE | GAP | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| February 26, 2008 | K080144 | MANDREL GUIDEWIRES OR M-WIRES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| January 15, 2008 | K073451 | PRESSURE INJECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| November 8, 2007 | K072247 | STERICAN HYPODERMIC NEEDLES | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 10, 2007 | K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 26, 2007 | K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| July 17, 2007 | K071111 | NON-ABSORBABLE SILK SUTURE | GAP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 15, 2007 | K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| August 24, 2006 | K061289 | ARROW PRESSURE INJECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| May 31, 2006 | K060200 | MICROTEK MEDICAL WARMING DRAPE | KKX | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| March 7, 2006 | K053442 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| March 16, 2005 | K032666 | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| March 8, 2005 | K043017 | PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 15, 2005 | K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT | DYB | Substantially Equivalent | Thomas Medical Products, Inc. | accessdata.fda.gov |
| August 27, 2004 | K042126 | PICC | LJS | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| July 12, 2004 | K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 4, 2004 | K041179 | MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services, Inc. | accessdata.fda.gov |
| May 14, 2004 | K040666 | STEP-TIP CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| March 5, 2004 | K040260 | INTEGRAL HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Arrow Int'L. | accessdata.fda.gov |
| March 1, 2004 | K040100 | ARROW ECHOGENIC INTRODUCER NEEDLE | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 13, 2004 | K040078 | CANNON II PLUS | MSD | Unknown | Arrow International, Inc. | accessdata.fda.gov |
| May 9, 2003 | K022662 | DIATEK CANNON-CATHETER, MODEL CC5500 | MSD | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| April 23, 2003 | K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| February 11, 2003 | K023419 | TRILAMINATE DRAPES/TIBURON | KKX | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
Compare with other makers
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Updated March 14, 2025. 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.