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2,312 FDA 510(k) clearances · Product code

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RecordFirmDate
Legend X Desktop System (K243217)Pollogen, Ltd.2024-11-01
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K242266)Stryker Instruments2024-10-21
Vybe RF II (K241535)ShenB Co., Ltd.2024-09-25
Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) (K242204)Dongguan Quanding Medical Supplies Co., Ltd.2024-09-25
FiAPC plus probes (K242044)Erbe Elektromedizin GmbH2024-08-26
CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) (K240782)Pulse Biosciences, Inc.2024-08-05
da Vinci E-200 Electrosurgical Generator (K241635)Intuitive Surgical2024-08-05
HybridTherm System (K240932)Erbe Elektromedizin GmbH2024-08-05
Da Vinci Monopolar and Bipolar Adapters (378896) (K241621)Intuitive Surgical2024-08-02
InMode RF System (K240780)InMode , Ltd.2024-07-24
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (K233644)Megadyne Medical Products, Inc.2024-07-12
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (K241085)Covidien, LLC2024-07-12
Sterile single use tip cleaner (WK800-S10 , WK800-S20) (K241022)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2024-07-11
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) (K240572)Covidien, LLC2024-07-01
Profound Matrix (K240070)Candela Corporation2024-07-01
SILKRO (K233123)Hironic Co., Ltd.2024-06-24
InMode System with the Morpheus8 90 Applicator (K240017)InMode , Ltd.2024-06-13
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- (K240657)Livsmed, Inc.2024-06-06
Electro Lube NXT (K241055)Steris2024-05-31
Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter (K232505)Zhejiang Curaway Medical Technology Co., Ltd.2024-05-30
CWM-930S, FIXER DV9 (K233120)Chungwoo Co., Ltd.2024-05-23
Gladiator (K233099)Rohrer Aesthetics, LLC2024-05-22
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027) (K241008)Relign Corporation, Subsidiary of Zimmer Biomet2024-05-08
Legend X Applicator VO (K240999)Pollogen, Ltd.2024-05-08
FLOW 90? Wand (K240964)ArthroCare Corporation2024-05-08
Volnewmer™ (K240248)Classys, Inc.2024-04-29
Kronos Electrocautery Device (K232805)Single Pass, Inc.2024-04-25
mJOULE RF System and Accessories (K222958)Sciton, Inc2024-04-23
BTL-499 (K233849)BTL Industries, Inc.2024-04-23
ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) (K234147)Microline Surgical, Inc.2024-04-23
BTL-785S (K233604)BTL Industries, Inc.2024-03-28
BEED 2,5, BEED 3,8 (K233002)Excelsior Resources, LLC2024-03-20
InMode RF System (K233642)InMode , Ltd.2024-03-20
Define RF Microneedling System (K232301)Aesthetic Management Partners2024-03-14
CellFX Percutaneous Electrode System (SYS3000) (K233705)Pulse Biosciences, Inc.2024-03-08
Disposable Bipolar Forceps (K232703)Jiangsu Hope Biomedical Science & Technology Co., Ltd.2024-03-06
PlazMagik (K230837)Agnes Medical Co., Ltd.2024-02-29
OsteoCool™ 2.0 RF Ablation System (K233830)Medtronic Sofamor Danek USA, Inc.2024-02-28
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (K233879)Maquet Cardiovascular, LLC2024-02-27
Oligio X (K240313)Wontech Co., Ltd.2024-02-22
Disposable Grounding Pad (K231985)Shenzhen Mecun Medical Supply Co., Ltd.2024-02-16
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G (K232072)H.S Hospital Service S.P.A2024-02-09
VIVA combo RF System (VIVA combo RF System) (K234140)Starmed Co., Ltd.2024-01-30
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) (K233425)Sutter Medizintechnik GmbH2024-01-25
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode (K231405)Jiangsu Rong FU Kang Medical Instruments Co., Ltd.2024-01-18
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 (K233615)Baisheng Medical Co., Ltd.2024-01-08
10THERMA (K232992)Tentech, Inc.2023-12-20
Secret Pro (K233374)Ilooda Co,., Ltd.2023-12-14
SIRA™ RFA Electrosurgical Device (K232947)Innoblative Designs, Inc.2023-12-12
INTELLIO SHIFT System (K232290)ArthroCare Corporation2023-12-11
Disposable Endoscopic Bipolar (K231615)Jiangsu Hope Biomedical Science & Technology Co., Ltd.2023-12-05
LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (K230621)Surgical Principals, Inc.2023-12-01
HYBRIDknife® flex (K232033)Erbe Elektromedizin GmbH2023-11-29
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) (K233493)Relign Corporation2023-11-28
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force (K233351)Hg Innovations, Ltd.2023-11-20
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); (K233346)Hg Innovations, Ltd.2023-11-20
CoolSeal Trinity (K231012)Bolder Surgical, LLC2023-11-15
POWERSEAL Sealer and Divider (K231327)Gyrus Acmi, Inc.2023-10-25
PiXel8-RF (K233147)Rohrer Aesthetics2023-10-25
VVR Generator system (K222997)Starmed Co., Ltd.2023-10-25
PlaDuo System (K232223)ShenB Co., Ltd.2023-10-24
MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System (K233185)C2dx, Inc.2023-10-24
CleanSeal Advanced Bipolar Vessel Sealer Maryland (K231732)Conmed Corporation2023-10-23
Radio Frequency System (K231749)Shenzhenshi Sincoheren S&T Development Co., Ltd.2023-10-19
Legend X Platform (K232903)Pollogen, Ltd.2023-10-17
The Evolve System with the Transform Applicator (K231495)InMode , Ltd.2023-10-13
Monopolar Electrode Surgical Instrument (K230650)Vhmed (Nantong) Co. , Ltd.2023-10-12
Cross Vascular RF Generator and Footswitch (optional accessory) (K232809)Cross Vascular, Inc.2023-10-12
Disposable electrosurgical pencil (MD1000) (K232460)Shenzhen Mecun Medical Supply Co., Ltd.2023-10-11
Cautery Protective Actuation System (CPAS) (K232407)Safer Surgeries Medical Devices, LLC2023-10-06
Electrode Handpieces (VCT, RFTV, BMDT series) (K232763)RF Medical Co., Ltd.2023-10-04
BTL-899F (K230467)BTL Industries, Inc.2023-09-21
AliTight (K231146)Alic Iotech, LLC2023-09-08
Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes (K221743)Jiangsu Bonss Medical Technology Co., Ltd.2023-09-07
Spinery™ RF Ablation System (K223303)Axon Spine Medical System2023-08-30
Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) (K231872)Kirwan Surgical Products, LLC2023-08-25
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (K231777)Olympus Winter & Ibe GmbH2023-08-18
Density (K230663)Jeisys Medical, Inc.2023-08-14
NuEra Tight RF Family (K223856)Bios S.R.L.2023-08-11
Eblator Device (K231126)E Surgical, LLC2023-08-02
The InMode System with the Morpheus8 Applicators (K231790)InMode , Ltd.2023-07-20
VYBE RF Electrosurgical System (K230968)ShenB Co., Ltd.2023-07-06
AblatePal Radiofrequency Ablation System (K223135)Compal Electronics, Inc.2023-06-30
ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) (K230914)ArthroCare Corporation2023-06-26
da Vinci E-200 Electrosurgical Generator (K231212)Intuitive Surgical2023-06-21
Tixel® 2 System (K223033)Novoxel , Ltd.2023-06-21
Renuvion® Micro Handpiece (K230586)Apyx Medical Corporation2023-06-09
ArtiSential Laparoscopic Instruments-Electrodes (K230498)Livsmed, Inc.2023-06-05
BTL-785X (K222556)BTL Industries, Inc.2023-05-31
Victan (K230593)Jiangsu Haize Medical Scientific Development Co., Ltd.2023-05-30
Single Use Bipolar Forceps (K230432)Hg Innovations, Ltd.2023-05-18
Agnes (K223805)Agnes Medical Co., Ltd.2023-05-04
ArtiSential Laparoscopic Instruments-Electrodes (K230539)Livsmed, Inc.2023-04-27
Renuvion® APR Handpiece (K230272)Apyx Medical Corporation2023-04-27
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter (K230547)Conmed Corporation2023-04-27
ArtiSential Laparoscopic Instruments-Electrodes (K230499)Livsmed, Inc.2023-04-26
SafeAir combi (SFR-combi-US) (K223932)Lina Medical Aps2023-04-26
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 (K223784)Deltronix Equipamentos Ltda2023-04-18
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) (K230387)Ethicon Endo-Surgery, LLC2023-04-13
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (K230255)Stryker Sustainability Solutions2023-03-28
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