General & Plastic Surgery devices: recent FDA 510(k) clearances

44 general & Plastic Surgery devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Stryker Instruments with 2. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

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44 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Stryker Instruments (2). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
44
Most frequent
  1. Stryker Instruments (2)
  2. Beijing Nubway S&T Co., Ltd. (2)
  3. Shenzhen Dongdixin Technology Co., Ltd. (1)
  4. Ezisurg Medical Co., Ltd. (1)
  5. BLUECORE COMPANY Co., Ltd. (1)

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What are the top general & Plastic Surgery devices: recent FDA 510(k) clearances right now?

RecordSpecialtyTypeDate
TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.General, Plastic Surgery510(k)2026-10-13
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.General, Plastic Surgery510(k)2026-09-25
PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.General, Plastic Surgery510(k)2026-09-24
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLCGeneral, Plastic Surgery510(k)2026-09-22
Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.General, Plastic Surgery510(k)2026-09-19
SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.General, Plastic Surgery510(k)2026-09-19
VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLCGeneral, Plastic Surgery510(k)2026-09-18
MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed CorporationGeneral, Plastic Surgery510(k)2026-09-18
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLCGeneral, Plastic Surgery510(k)2026-09-17
Potenza Prime (K254185): 510(k) cleared for Jeisys Medical IncorporatedGeneral, Plastic Surgery510(k)2026-09-11
Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical LimitedGeneral, Plastic Surgery510(k)2026-10-21
Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd.General, Plastic Surgery510(k)2026-10-13
MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.General, Plastic Surgery510(k)2026-10-08
Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.General, Plastic Surgery510(k)2026-09-28
ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc.General, Plastic Surgery510(k)2026-10-21
RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd. 🔒 Unlock all 44 records →
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. 🔒 Unlock all 44 records →
PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd 🔒 Unlock all 44 records →
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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

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Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many general & Plastic Surgery devices: recent FDA 510(k) clearances are listed?

44 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

Can I get alerts for General & Plastic Surgery devices: recent FDA 510(k) clearances?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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