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Data / FDA device clearances / General, Plastic Surgery

General, Plastic Surgery device clearances: 992

The full list. FDA general, plastic surgery device clearances and approvals: 992 rows for $49.60, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 41 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 992 device decisions in general, plastic surgery (FDA review panel) from November 12, 2024 to October 30, 2026: 737 510(k) clearances and De Novo grants and 255 PMA approvals and supplements, for 498 applicants. The newest, K263063 on October 30, 2026, is B`orze Inc Laser Family (Sorren/Adonis) from Borze, Inc..

The request: Every new FDA clearance or approval of a general, plastic surgery device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

  • 992Decisions
  • 737510(k) and De Novo
  • 255PMA
  • October 30, 2026Latest decision

Newest decisions

The newest 100 of 992, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026K263063B`orze Inc Laser Family (Sorren/Adonis)Borze, Inc.IdahoSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 30, 2026K260306RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit...Smith & Nephew Medical, Ltd.United KingdomSubstantially Equivalent510(k) traditionalOMPaccessdata.fda.gov
October 28, 2026K262343DynaviscFziomed, Inc.CaliforniaSubstantially Equivalent510(k) traditionalOWWaccessdata.fda.gov
October 28, 2026K261636Microwave Ablation AntennasCanyon Medical, Inc.ChinaSubstantially Equivalent510(k) traditionalNEYaccessdata.fda.gov
October 28, 2026K261630GI Windows Flexagon Plus OTOLoc SystemGI Windows SurgicalMassachusettsSubstantially Equivalent510(k) traditionalSAHaccessdata.fda.gov
October 28, 2026K260310HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalQSOaccessdata.fda.gov
October 27, 2026K263461Tendon AnchorSmith & Nephew, Inc.MassachusettsSubstantially Equivalent510(k) specialGDWaccessdata.fda.gov
October 27, 2026K262349Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)Risu Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 27, 2026K260520Skin Clinic Nitro Clear for Warts and Skin TagsCryoconcepts LPPennsylvaniaSubstantially Equivalent510(k) traditionalGEHaccessdata.fda.gov
October 26, 2026P250034/S004Optune PaxNovocure, GmbH30-day notice acceptedPMA 30-day noticeSHCaccessdata.fda.gov
October 26, 2026K262984Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06...Shenzhen Bway Tech Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOHSaccessdata.fda.gov
October 26, 2026K262720SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)Single Pass, Inc.CaliforniaSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
October 26, 2026K262627Fractional CO2 Laser Therapy System (Z121)Sanhe PERFECTLASER Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 23, 2026P990075/S071Saline-Filled and Spectrum™ Breast ImplantsMentor Worldwide, LLCCalifornia30-day notice acceptedPMA 30-day noticeFWMaccessdata.fda.gov
October 23, 2026P220024/S007LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hernia Mesh Fixation...Advanced Medical Solutions LimitedApprovedPMA 180-day supplementPLJaccessdata.fda.gov
October 23, 2026P060028/S063MemoryShape™ Breast ImplantsMentor Worldwide, LLCCalifornia30-day notice acceptedPMA 30-day noticeFTRaccessdata.fda.gov
October 23, 2026P030053/S093MemoryGel™ Breast ImplantsMentor Corp.California30-day notice acceptedPMA 30-day noticeFTRaccessdata.fda.gov
October 23, 2026K262752Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOHSaccessdata.fda.gov
October 23, 2026K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)Smith & Nephew Medical, Ltd.United KingdomSubstantially Equivalent510(k) traditionalOMPaccessdata.fda.gov
October 22, 2026K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.LtdChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 21, 2026P990075/S070MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESMentor Worldwide, LLCCalifornia30-day notice acceptedPMA 30-day noticeFWMaccessdata.fda.gov
October 21, 2026P250016/S006Belotero Intense (+) Lidocaine Dermal FillerMerz North America, Inc.North Carolina30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
October 21, 2026K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc.OhioSubstantially Equivalent510(k) specialPZXaccessdata.fda.gov
October 21, 2026K261252Versius Surgical System (Versius Plus)Cmr Surgical LimitedUnited KingdomSubstantially Equivalent510(k) traditionalSCVaccessdata.fda.gov
October 20, 2026K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 20, 2026K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch...Stryker InstrumentsMichiganSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
October 19, 2026K262932AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)Shenzhen Accompany Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOHSaccessdata.fda.gov
October 16, 2026K262443Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)Sofradim ProductionFranceSubstantially Equivalent510(k) traditionalOWTaccessdata.fda.gov
October 16, 2026K262284KIM BLUEDesarrollo e Investigación Médica Aragonesa S.L.SpainSubstantially Equivalent510(k) traditionalOTNaccessdata.fda.gov
October 14, 2026P160042/S032Revanesse Versa, Revanesse Versa+ (with lidocaine) and Revanesse Lips+ (with lidocaine)Prollenium Medical Technologies, Inc.30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
October 14, 2026K262885308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)Guangxi Hope Medical Devices Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalFTCaccessdata.fda.gov
October 13, 2026K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 13, 2026K252288TECAR Therapy Device (TC2000, TC2001)Shenzhen Dongdixin Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalPBXaccessdata.fda.gov
October 9, 2026K262352IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)Shenzhen Jianchao Intelligent Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOHTaccessdata.fda.gov
October 8, 2026P250021/S002saypha® ChiQ™Croma-Pharma GmbHApprovedPMA 180-day supplementLMHaccessdata.fda.gov
October 8, 2026K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight...Wuhan Phomed Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 8, 2026K260426MeCare Alpha (MCA2019)IVT Medical, Ltd.IsraelSubstantially Equivalent510(k) traditionalOMPaccessdata.fda.gov
October 7, 2026P250021/S001saypha® ChiQ™Croma-Pharma GmbHApprovedPMA 180-day supplementLMHaccessdata.fda.gov
October 7, 2026K262822Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)Zhongshan GL Electronics Co. , Ltd.ChinaSubstantially Equivalent510(k) traditionalBTAaccessdata.fda.gov
October 7, 2026K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 5, 2026K262285UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)Shijiazhuang Recovery Star Medical Device Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalFTCaccessdata.fda.gov
October 2, 2026P230005/S002Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone...Motiva USA, LLCCaliforniaApprovedPMA 180-day supplementFTRaccessdata.fda.gov
September 30, 2026K261975Braun Aura 7 (6041)CyDen LimitedUnited KingdomSubstantially Equivalent510(k) specialOHTaccessdata.fda.gov
September 29, 2026P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc.Massachusetts30-day notice acceptedPMA 30-day noticeLMFaccessdata.fda.gov
September 29, 2026P020056/S064Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast ImplantsAllerganCaliforniaApprovedPMA 180-day supplementFTRaccessdata.fda.gov
September 29, 2026K263073Fast Absorbing PGLARiverpoint Medical, LLCOregonSubstantially Equivalent510(k) specialGAMaccessdata.fda.gov
September 28, 2026K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.Rhode IslandSubstantially Equivalent510(k) traditionalOWTaccessdata.fda.gov
September 28, 2026K260474Liora Monofilament ScaffoldTELA Bio, Inc.PennsylvaniaSubstantially Equivalent510(k) traditionalFTLaccessdata.fda.gov
September 25, 2026P230005/S005Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast ImplantsMotiva USA, LLCCaliforniaApprovedPMA 135-day supplementFTRaccessdata.fda.gov
September 25, 2026K261977Braun Aura 9 (6042)Cyden LimitedUnited KingdomSubstantially Equivalent510(k) specialOHTaccessdata.fda.gov
September 25, 2026K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic...Ezisurg Medical Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGDWaccessdata.fda.gov
September 24, 2026K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 22, 2026K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLCFloridaSubstantially Equivalent510(k) traditionalPBXaccessdata.fda.gov
September 19, 2026K252723Dynamis Pro FamilyFotona D.O.O.SloveniaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 19, 2026K241973SmartIPL_NI SystemLumenis Be, Ltd.IsraelSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 18, 2026P990004/S080SURGIFOAM® Absorbable Gelatin SpongeFerrosan Meidcal Devices A/SApprovedPMA 180-day supplementLMFaccessdata.fda.gov
September 18, 2026P900033/S117INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft...Integra Lifesciences Corp.New Jersey30-day notice acceptedPMA 30-day noticeMGRaccessdata.fda.gov
September 18, 2026P850010/S119Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar...Integra LifeSciences CorporationNew Jersey30-day notice acceptedPMA 30-day noticeLMFaccessdata.fda.gov
September 18, 2026P810006/S115Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent...Integra LifeSciences CorporationNew Jersey30-day notice acceptedPMA 30-day noticeLMFaccessdata.fda.gov
September 18, 2026P140029/S058Restylane® ContourQ-Med ABApprovedPMA 180-day supplementLMHaccessdata.fda.gov
September 18, 2026K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalOHTaccessdata.fda.gov
September 18, 2026K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 18, 2026K254238MINT MONO SuturesHans Biomed CorporationSouth KoreaSubstantially Equivalent510(k) traditionalNEWaccessdata.fda.gov
September 18, 2026K254160VacHeal Negative Pressure Wound Therapy SystemVacHeal, LLCPennsylvaniaSubstantially Equivalent510(k) traditionalOKOaccessdata.fda.gov
September 17, 2026P030050/S056SCULPTRA® (injectable poly-L Lactic acid)Q-Med AB30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
September 17, 2026K262073Hygienic Protective Bite Cover (2207-010-50)Dürr Dental SEGermanySubstantially Equivalent510(k) traditionalPEMaccessdata.fda.gov
September 17, 2026K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch...Stryker InstrumentsMichiganSubstantially Equivalent510(k) specialGEIaccessdata.fda.gov
September 17, 2026K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 17, 2026K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 17, 2026K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.ItalySubstantially Equivalent510(k) traditionalFZPaccessdata.fda.gov
September 17, 2026K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCPuerto RicoSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
September 16, 2026K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser...Olympus Surgical Technologies AmericaMassachusettsSubstantially Equivalent510(k) specialGEXaccessdata.fda.gov
September 16, 2026K261467GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)Gt Metabolic Solutions, Inc.MinnesotaSubstantially Equivalent510(k) traditionalSAHaccessdata.fda.gov
September 15, 2026K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCColoradoSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
September 13, 2026K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalFMKaccessdata.fda.gov
September 11, 2026K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.CanadaSubstantially Equivalent510(k) traditionalQPCaccessdata.fda.gov
September 11, 2026K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.United KingdomSubstantially Equivalent510(k) traditionalOMPaccessdata.fda.gov
September 11, 2026K254185Potenza PrimeJeisys Medical IncorporatedSouth KoreaSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
September 10, 2026P250020/S005Belotero Volume (+) Lidocaine Dermal FillerMerz North America, Inc.North Carolina30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
September 10, 2026K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 10, 2026K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 10, 2026K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalNADaccessdata.fda.gov
September 8, 2026K261956Dental Barriers and Sleeves (AB0006)ANI Co., Ltd.South KoreaSubstantially Equivalent510(k) traditionalPEMaccessdata.fda.gov
September 5, 2026K254135LipoSurg ARTISTNouvag AGSwitzerlandSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
September 3, 2026P170012/S032HEMOBLAST™ BellowsDilon Technologies, Inc.VirginiaApprovedPMA 180-day supplementPMXaccessdata.fda.gov
September 3, 2026K262315NeuroBlate SystemMonteris MedicalMinnesotaSubstantially Equivalent510(k) traditionalONOaccessdata.fda.gov
September 2, 2026K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalCaliforniaSubstantially Equivalent510(k) traditionalGEHaccessdata.fda.gov
September 2, 2026K262364Ellian Enigma RF DeviceEllian CorpTexasSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
September 2, 2026K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 1, 2026K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
September 1, 2026K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple...PRIMED Medical Products, Inc.CanadaSubstantially Equivalent510(k) traditionalQSOaccessdata.fda.gov
August 31, 2026P250016/S004Belotero® Intense (+) LidocaineMerz North America, Inc.North CarolinaApprovedPMA 180-day supplementLMHaccessdata.fda.gov
August 31, 2026P170002/S059RHA 2, RHA 3, RHA 4Teoxane S.A.30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
August 31, 2026K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask...Kam Yuen Plastic Products , Ltd.ChinaSubstantially Equivalent510(k) traditionalOHSaccessdata.fda.gov
August 28, 2026P170002/S058RHA 2, RHA 3, RHA 4Teoxane S.A.30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
August 28, 2026P110033/S102Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by JuvédermAllerganCalifornia30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
August 28, 2026P050047/S107Juvéderm Ultra XC, and Juvéderm Ultra Plus XCAllerganCalifornia30-day notice acceptedPMA 30-day noticeLMHaccessdata.fda.gov
August 28, 2026K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalNUVaccessdata.fda.gov
August 27, 2026P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc.New JerseyApprovedPMA 180-day supplementSGVaccessdata.fda.gov
August 27, 2026K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.ChinaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Merz North America, Inc.44October 21, 2026
ETHICON, Inc.29August 27, 2026
Allergan28September 29, 2026
Mentor Worldwide, LLC21October 23, 2026
Mentor Corp.19October 23, 2026
Q-Med AB15September 18, 2026
Teoxane S.A.14August 31, 2026
Shenzhen Kaiyan Medical Equipment Co., Ltd.14June 16, 2026
Ferrosan Meidcal Devices A/S13September 18, 2026
Shenzhen Ulike Smart Electronics Co., Ltd.11May 21, 2026
Integra LifeSciences Corporation9September 18, 2026
Wontech Co., Ltd.9December 19, 2025
Zhengzhou PZ Laser Slim Technology Co., Ltd.8September 17, 2026
Tianjin Huahong Technology Co., Ltd.8September 13, 2026
Beijing Nubway S&T Co., Ltd.7October 7, 2026
Tiger Aesthetics Medical, LLC7August 7, 2026
Davol Inc., Sub. C. R. Bard, Inc.7July 15, 2026
Smith & Nephew Medical, Ltd.6October 30, 2026
Ethicon Endo-Surgery, LLC6September 17, 2026
Baxter Healthcare Corporation6August 7, 2026

By decision type

Decision typeDecisionsLatest
510(k) traditional619October 30, 2026
PMA 30-day notice161October 26, 2026
510(k) special109October 27, 2026
PMA 180-day supplement45October 23, 2026
PMA real-time process supplement16July 27, 2026
PMA 135-day supplement14September 25, 2026
PMA original approval8July 9, 2026
PMA panel track supplement7June 25, 2026
510(k) abbreviated5July 10, 2026
De Novo4July 21, 2026
PMA special supplement4January 14, 2026

By state or country

State or countryDecisionsLatest
China249October 28, 2026
California114October 28, 2026
South Korea68September 24, 2026
New Jersey46September 18, 2026
Massachusetts39October 28, 2026
Wisconsin37June 26, 2026
Israel25October 8, 2026
Florida20September 22, 2026
United Kingdom19October 30, 2026
North Carolina18October 21, 2026
Germany17September 17, 2026
Italy17September 17, 2026
Illinois17August 11, 2026
Rhode Island14September 28, 2026
Canada13September 11, 2026
Pennsylvania12October 27, 2026
Taiwan12August 25, 2026
Ohio11October 21, 2026
Texas10September 2, 2026
Tennessee10August 18, 2026
New York10July 10, 2026
France9October 16, 2026
Spain9October 16, 2026
Switzerland9September 5, 2026
Georgia8October 28, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. 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.