FDA 510(k) clearances and recalls: General & Plastic Surgery devices
44 FDA 510(k) clearances and recalls: General & Plastic Surgery devices 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
Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
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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- Stryker Instruments (2)
- Beijing Nubway S&T Co., Ltd. (2)
- Shenzhen Dongdixin Technology Co., Ltd. (1)
- Ezisurg Medical Co., Ltd. (1)
- BLUECORE COMPANY Co., Ltd. (1)
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What are the top FDA 510(k) clearances and recalls: General & Plastic Surgery devices right now?
Browse 29 more matching record reports
- RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) (K261982): 510(k) cleared for Smith & Nephew Medical, Ltd.
- Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
- PicoPeak Picosecond Nd:Yag Laser System (Bella-9) (K262701): 510(k) cleared for Beijing Sea Heart International Science and Technologyco.Ltd
- Dental Diode Laser Device (Laser-Pen) (K261047): 510(k) cleared for Guilin Kevin Peter Technology Co., Ltd.
- Vessel Closure Device (VCD177213P) (K260677): 510(k) cleared for Vcd Medical S.R.L.
- LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated (K261070): 510(k) cleared for Covidien, LLC
- Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited
- Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC
- Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited
- Picosecond Laser treatment system (Z180) (K262628): 510(k) cleared for Sanhe PERFECTLASER Technology Co., Ltd.
- SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared for Stryker Instruments
- AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) (K262932): 510(k) cleared for Shenzhen Accompany Technology Co., Ltd.
- Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (K262443): 510(k) cleared for Sofradim Production
- KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.
- 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd.
- IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) (K262352): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd.
- CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) (K262346): 510(k) cleared for Wuhan Phomed Technology Co., Ltd
- Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) (K262822): 510(k) cleared for Zhongshan GL Electronics Co. , Ltd.
- Diode Laser Hair Removal Machine (QDTM-03) (K261692): 510(k) cleared for Beijing Nubway S&T Co., Ltd.
- UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) (K262285): 510(k) cleared for Shijiazhuang Recovery Star Medical Device Co., Ltd.
- Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R
- SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K262877): 510(k) cleared for Olympus Surgical Technologies America
- Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.
- LED Therapy Device (QLXY-01) (K261673): 510(k) cleared for Beijing Nubway S&T Co., Ltd.
- Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (K261817): 510(k) cleared for Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Hygienic Protective Bite Cover (2207-010-50) (K262073): 510(k) cleared for Dürr Dental SE
- GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc.
- Safety lancet (XL) (K262526): 510(k) cleared for Tianjin Huahong Technology Co., Ltd.
Which related categories and locations should I check?
Browse by record type
510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)
Browse by specialty
Radiology (56) Orthopedic (53) Cardiovascular (52) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)
Browse by record type by specialty
Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) 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 FDA 510(k) clearances and recalls: General & Plastic Surgery devices 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?
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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