Data / Medical devices / United States / Smith & Nephew Inc.
Smith & Nephew Inc.: FDA-registered device maker in Oklahoma City, OK, United States, 161 510(k) clearances
Smith & Nephew Inc. is registered with the FDA (registration 1643264) in Oklahoma City, OK, United States. It lists 109 device types. The FDA files 161 510(k) clearances under its listings, the newest dated September 8, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1643264
- Address
- Endoscopy 76 S. Meridian Ave., Oklahoma City, OK, United States, 73107
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- February 22, 1978
- Registered through
- 2026
- Brand names listed
- (curette, probe, rasp, osteotome ), 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796, 1.2 RAP-PAC B LATEX FREE, 1.2 RAP-PAC B, 72202797, 1.2 RAP-PAC C, 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189 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 161.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K261462 | LANDMARK Total Knee System | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 6, 2026 | DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | SIQ | Unknown | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 26, 2026 | K260601 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| December 5, 2025 | K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| March 18, 2024 | K240139 | Real Intelligence CORI | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| December 11, 2023 | K232290 | INTELLIO SHIFT System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 8, 2022 | K223112 | MAVERICK Mini External Fixation System | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 20, 2022 | K221740 | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) | GCJ | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| September 29, 2022 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 6, 2022 | K221929 | Smith+Nephew INTELLIO Tablet | ODA | Substantially Equivalent | Smith+Nephew | accessdata.fda.gov |
| August 25, 2022 | K221792 | Acute QC Strut and Components | OSN | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 19, 2022 | K221224 | REAL INTELLIGENCE CORI | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| November 3, 2021 | K212537 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| July 29, 2021 | K210953 | SMART Taylor Spatial Frame | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 29, 2021 | K210837 | Smith & Nephew Plates and Screws | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 13, 2021 | K203566 | Tablet Application | ODA | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| July 20, 2020 | K201349 | Smith+Nephew Arthroscopes | HRX | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| July 17, 2020 | K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | GCJ | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| June 12, 2020 | K201022 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| February 27, 2020 | K192876 | INTELLIO Tablet Application | ODA | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| February 14, 2020 | K193120 | Real Intelligence Cori | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| November 21, 2019 | K190439 | Engage Partial Knee System | NJD | Substantially Equivalent | Engage Uni, LLC | accessdata.fda.gov |
| August 23, 2019 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | GCJ | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| March 12, 2019 | K183232 | Double ENDOBUTTON Fixation Device | HTN | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| February 11, 2019 | K190085 | Journey II Unicompartmental Knee System | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 21, 2017 | K171073 | Smith & Nephew, Inc. REDAPT Augments | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 16, 2017 | K173331 | JOURNEY II XR Knee Instruments | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2017 | K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 27, 2017 | K171794 | Smith & Nephew 25 Fluid Management System | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2017 | K170977 | SURESHOT Distal Targeting System V4.0 Trauma Interface | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 2, 2017 | K170360 | NAVIO | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| April 28, 2017 | K170280 | Smith & Nephew SURESHOT Distal Targeting System V4.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 13, 2017 | K162775 | Legion Cone System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 6, 2017 | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | GAT | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 18, 2016 | K162078 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 15, 2016 | K161665 | VLP Wrist Fracture System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 22, 2016 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 2, 2016 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application | GCJ | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| May 19, 2016 | K160537 | Navio | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| January 19, 2016 | K153669 | MultiFIX S Ultra Knotless Fixation System | MBI | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| October 20, 2015 | K152574 | Navio | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| December 22, 2014 | K142807 | ANTHEM PS Total Knee System | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 18, 2014 | K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 15, 2014 | K133662 | SMITH & NEPHEW CANNULATED CAPTURED SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 14, 2014 | K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 13, 2014 | K140970 | ONE-PIECE PEEK FUSION IMPLANT | HWC | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| April 7, 2014 | K133235 | THREADED PEEK K-WIRE | MBI | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| March 28, 2014 | K133515 | PEEK FUSION IMPLANT | HWC | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| February 4, 2014 | K132886 | SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133229 | TITANIUM SUTURE ANCHOR | MBI | Substantially Equivalent | Mtp Solutions, LLC | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 7, 2014 | K132296 | D-RAD SMART PACK | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 9, 2013 | K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| July 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 28, 2013 | K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 31, 2013 | K123380 | STRIDE UNICONDYLAR KNEE | HSX | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| April 11, 2013 | K123393 | HEALICOIL SUTURE ANCHOR WITH REGENESORB | MAI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 18, 2013 | K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2013 | K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 20, 2013 | K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 25, 2013 | K123055 | SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 7, 2012 | K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| October 19, 2012 | K122170 | SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 7, 2012 | K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | HSD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 13, 2012 | K121443 | JOURNEY II CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 7, 2012 | K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 12, 2012 | K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| June 7, 2012 | K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 27, 2012 | K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 5, 2012 | K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2011 | K111843 | ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | OLO | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| September 16, 2011 | K111711 | JOURNEY II BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 24, 2011 | K110545 | SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110240 | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 13, 2010 | K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| September 27, 2010 | K093047 | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 21, 2010 | K101448 | OPUS SPEEDSCREW SYSTEM | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 23, 2010 | K100107 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 4, 2009 | K093165 | ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| September 11, 2009 | K092497 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 23, 2009 | K090393 | ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 17, 2009 | K091503 | MAGNUM MP FIXATION DEVICE | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| March 3, 2009 | K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 6, 2009 | K082750 | ENTACT SEPTAL STAPLER, MODEL 610-00100 | OLL | Substantially Equivalent | Entrigue Surgical, Inc. | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 15, 2008 | K082666 | ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 1, 2008 | K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 | HWC | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| July 28, 2008 | K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 23, 2008 | K080358 | PLLA, HA SCREW | HWC | Substantially Equivalent | Smith & Nephew Inc., Endoscopy Div. | accessdata.fda.gov |
| February 15, 2008 | K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 25, 2007 | K070374 | ARTHROCARE ENT PLASMA WAND | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 16, 2007 | K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 2, 2007 | K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | GAT | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| February 22, 2007 | K070266 | 560 HIGH DEFINITION CAMERA SYSTEM | GCJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2007 | K062849 | SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM | HRX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 13, 2006 | K060777 | SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM | GCJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2007 | 37849 | Not yet classified | Terminated | Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810. | Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use. | accessdata.fda.gov |
| January 19, 2007 | 37819 | Not yet classified | Terminated | SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810. | Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT) | accessdata.fda.gov |
| November 1, 2006 | 37792 | Not yet classified | Terminated | Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810. | The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board. | accessdata.fda.gov |
| October 12, 2004 | 37614 | Not yet classified | Terminated | Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810. | Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery. | accessdata.fda.gov |
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Updated September 8, 2026. 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.