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Data / Medical devices / United States / Ambler Surgical, LLC

Ambler Surgical, LLC: FDA-registered device maker in Exton, PA, United States, 20 510(k) clearances

Ambler Surgical, LLC is registered with the FDA (registration 3005528784) in Exton, PA, United States. It lists 220 device types. The FDA files 20 510(k) clearances under its listings, the newest dated May 10, 2013. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Ambler Surgical, LLC
FDA registration number
3005528784
Address
436 Creamery Way Ste 300, Exton, PA, United States, 19341
Owner or operator
AMBLER SURGICAL, LLC (9106120)
Roles
Repackager or relabeler
First device listed
August 21, 2007
Registered through
2027
Brand names listed
Ambler, Ambler Surgical, Amlber, Amnler, Honan

Devices it lists

DeviceProduct codeClassRoleSource
AdenotomeKBH1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Repackager or relabeleraccessdata.fda.gov
Applicator, Ocular PressureLCC2Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Repackager or relabeleraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-DisposableFBM1Repackager or relabeleraccessdata.fda.gov
Cannula, EarJYC1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Cannula, VentricularHCD1Repackager or relabeleraccessdata.fda.gov
Cannulae, BronchialKCE1Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Chisel, MastoidJYD1Repackager or relabeleraccessdata.fda.gov
Chisel, Middle-EarJYE1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Clamp, Eyelid, OphthalmicHOD1Repackager or relabeleraccessdata.fda.gov
Clamp, Muscle, OphthalmicHOB1Repackager or relabeleraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Repackager or relabeleraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Repackager or relabeleraccessdata.fda.gov
Clamp, PenileFHA1Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Repackager or relabeleraccessdata.fda.gov
Clamp, UterineHGC1Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Repackager or relabeleraccessdata.fda.gov
Conformer, OphthalmicHQN2Repackager or relabeleraccessdata.fda.gov
CorkscrewHWI1Repackager or relabeleraccessdata.fda.gov
CountersinkHWW1Repackager or relabeleraccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Repackager or relabeleraccessdata.fda.gov
Curette, EthmoidKAO1Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Repackager or relabeleraccessdata.fda.gov
DetergentJCB1Repackager or relabeleraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Repackager or relabeleraccessdata.fda.gov
Dilator, CatheterGCC1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, RectalFFP1Repackager or relabeleraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
ExpressorHNS1Repackager or relabeleraccessdata.fda.gov
FileHTP1Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, ObstetricalHDA2Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
Gauge, MeasuringJYJ1Repackager or relabeleraccessdata.fda.gov
Goniometer, NonpoweredKQW1Repackager or relabeleraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Repackager or relabeleraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Hook, Tonsil SuturingKBP1Repackager or relabeleraccessdata.fda.gov
Hook, TrachealKCH1Repackager or relabeleraccessdata.fda.gov
ImpactorHWA1Repackager or relabeleraccessdata.fda.gov
Implant, Eye SphereHPZ2Repackager or relabeleraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Repackager or relabeleraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Introducer, SphereHNP1Repackager or relabeleraccessdata.fda.gov
Irrigator, SinusKAR1Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Repackager or relabeleraccessdata.fda.gov
Knife, LaryngealJZY1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Repackager or relabeleraccessdata.fda.gov
Knife, OrthopedicHTS1Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Knife, TonsilKBQ1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, OcularHMR1Repackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Repackager or relabeleraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Repackager or relabeleraccessdata.fda.gov
Mobilizer, EntKAJ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager or relabeleraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Repackager or relabeleraccessdata.fda.gov
PasserHWQ1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Repackager or relabeleraccessdata.fda.gov
Probe, EntKAK1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Repackager or relabeleraccessdata.fda.gov
Probe, TrabeculotomyHNK1Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Rasp, EarJYY1Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Repackager or relabeleraccessdata.fda.gov
Rod, Measuring EarJYZ1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Repackager or relabeleraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager or relabeleraccessdata.fda.gov
Scissors, EpisiotomyHDK1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Repackager or relabeleraccessdata.fda.gov
Scissors, UmbilicalHDJ1Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, Non-SterileNNU1Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Snare, EarJZD1Repackager or relabeleraccessdata.fda.gov
Snare, EnucleatingHNE1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Repackager or relabeleraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Repackager or relabeleraccessdata.fda.gov
Sound, Metal, InterconnectedFBS1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Specula AccessoriesFXG1Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, Non-IlluminatedFXE1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Sponge, OphthalmicHOZ2Repackager or relabeleraccessdata.fda.gov
Spoon, OphthalmicHNB1Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Repackager or relabeleraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Repackager or relabeleraccessdata.fda.gov
TampHXG1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Repackager or relabeleraccessdata.fda.gov
TonsillectomeKCA1Repackager or relabeleraccessdata.fda.gov
Tourniquet, Gastro-UrologyEYR1Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Repackager or relabeleraccessdata.fda.gov
TrocarDRC2Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager or relabeleraccessdata.fda.gov
Unit, Cautery, Thermal, Battery-PoweredHQP2Repackager or relabeleraccessdata.fda.gov
WrenchHXC1Repackager or relabeleraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 10, 2013K123478STINGRAY BIPOLAR FORCEPSGEISubstantially EquivalentStingray Surgical Productsaccessdata.fda.gov
July 20, 2012K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)HQPSubstantially EquivalentBovie Medical Corporationaccessdata.fda.gov
September 15, 2011K112176SILICONE SPHERESHPZSubstantially EquivalentOculo Plastik, Inc.accessdata.fda.gov
August 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWPSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
December 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 8, 2008K081651INSTRUMED RONGEURHAESubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 2, 2007K071771INSTRUMED RETRACTORSGZTSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
June 10, 2004K040689EYE SPHERE IMPLANTSHPZSubstantially EquivalentOculo Plastik, Inc.accessdata.fda.gov
April 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEISubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
June 24, 1998K974594SEMKIN BIPOLAR FORCEPHTDSubstantially EquivalentTitan Mfg., Inc.accessdata.fda.gov
October 3, 1997K972661EYE SPHERE, CONFORMERSHPZSubstantially EquivalentGulden Ophthalmicsaccessdata.fda.gov
September 1, 1995K953484POLLUX OA/POLLUX 30A/POLLUX 70AHRXSubstantially EquivalentPollux Endoscopy, Inc.accessdata.fda.gov
May 8, 1995K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKYSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
April 9, 1990K900533DISPOSABLE BIPOLAR COAGULATING FORCEPSGEISubstantially EquivalentKirwan Surgical Products, Inc.accessdata.fda.gov
January 20, 1987K864402BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBEGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov
June 2, 1983K831236BIPOLAR CARDGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov
March 25, 1982K820526RELIEF VALVE-HONAN INTRAOC. PRESSURELCCSubstantially EquivalentThe Lebanon Corp.accessdata.fda.gov
July 28, 1981K811820BIPOLAR COAGULATING FORCEPSGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated May 10, 2013. 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.