Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2014 | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation | GEI |
| Oct 31, 2014 | K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corporation | GEI |
| Oct 28, 2014 | K132771 | KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS Qingdao Kingston Medical Devices, Ltd., CN | GEI |
| Oct 23, 2014 | K142757 | LiNA PowerBlade Plus HC Lina Medical Aps, DK | GEI |
| Oct 21, 2014 | K141904 | VIORA V-TOUCH Viora , Ltd., IL | GEI |
| Oct 6, 2014 | K142538 | LiNA SafeAir Smoke Pencil Lina Medical Aps, DK | GEI |
| Oct 1, 2014 | K142364 | Barrx RFA Self Sizing Balloon Catheter Covidien, LLC | GEI |
| Sep 15, 2014 | K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 Ethicon Endo-Surgery, LLC | GEI |
| Aug 22, 2014 | K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE Applied Medical Resources | GEI |
| Aug 21, 2014 | K141357 | BARRX FLEX RFA ENERGY GENERATOR Covidien Iic | GEI |
| Aug 14, 2014 | K141153 | LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED Covidien | GEI |
| Aug 12, 2014 | K141225 | ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD Olympus Winter & Ibe GmbH | GEI |
| Aug 5, 2014 | K141858 | CLOSURERFG RADIOFREQUENCY GENERATOR Covidien | GEI |
| Aug 5, 2014 | K140896 | VAPR ARCTIC SUCTION ELECTRODE Depuy Mitek, A Johnson & Johnson Company | GEI |
| Jul 31, 2014 | K140603 | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM Saphena Medical, Inc. | GEI |
| Jul 30, 2014 | K141484 | OPEN FMSEALER Domain Surgical, Inc. | GEI |
| Jul 30, 2014 | K132797 | L'DISQ U&I Corporation, KR | GEI |
| Jul 29, 2014 | K140500 | SKINTACT Leonhard Lang GmbH | GEI |
| Jul 23, 2014 | K140578 | ARTHROSCOPIC ENERGY SYSTEM Conmed Corporation | GEI |
| Jul 11, 2014 | K140459 | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM Conmed Corporation | GEI |
| Jul 10, 2014 | K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES Conmed Corporation | GEI |
| Jun 25, 2014 | K140629 | VENUS SWAN(MP)2 Venus Concept , Ltd., IL | GEI |
| Jun 16, 2014 | K140006 | ENDOSHIELD BURN PROTECTION SYSTEM Encision, Inc. | GEI |
| Jun 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH ArthroCare Corporation | GEI |
| Jun 5, 2014 | K140422 | HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM Het Systems, LLC | GEI |
| May 23, 2014 | K140384 | FMWAND HANDPIECE SE Domain Surgical, Inc. | GEI |
| May 23, 2014 | K133405 | MINNIE Elettronica Valseriana Srl, IT | GEI |
| May 19, 2014 | K132703 | THUNDERBEAT Olympus Medical Systems Corp. | GEI |
| May 14, 2014 | K140255 | STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) Pollogen, Ltd. | GEI |
| Apr 28, 2014 | K140839 | CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. | GEI |
| Apr 17, 2014 | K140495 | LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE Boston Scientific Corp | GEI |
| Mar 17, 2014 | K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR Bovie Medical Corporation | GEI |
| Feb 12, 2014 | K133273 | LIGER MEDICAL ESU-110 Liger Medical, LLC | GEI |
| Jan 31, 2014 | K131696 | VESALIUS Telea Electronic Engineering Srl, IT | GEI |
| Jan 24, 2014 | K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Jan 24, 2014 | K132300 | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE Applied Medical Resources Corp. | GEI |
| Jan 7, 2014 | K133167 | MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD Intuitive Surgical, Inc. | GEI |
| Dec 20, 2013 | K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) Covidien, Formerly Valleylab, A Division of Tyco H | GEI |
| Dec 19, 2013 | K132837 | LINA POWERBLADE PLUS Lina Medical Aps | GEI |
| Dec 18, 2013 | K131758 | SURGEN U Pollogen, Ltd. | GEI |
| Dec 12, 2013 | K132754 | NEOGEN PSR SYSTEM Energist, Ltd., GB | GEI |
| Dec 11, 2013 | K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES Erbe USA, Inc. | GEI |
| Dec 6, 2013 | K130669 | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS Olsen Medical | GEI |
| Dec 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR Medtronic Advanced Energy, LLC | GEI |
| Dec 3, 2013 | K132743 | HARVESTING CANNULA Maquet Cardiovascular, LLC | GEI |
| Nov 15, 2013 | K130689 | SYMPHONY RF GENERATOR Thermigen, Inc. | GEI |
| Oct 25, 2013 | K131058 | BIPOLAR FORCEPS Boston Endo-Surgical Technologies, Inc. | GEI |
| Oct 16, 2013 | K122949 | MEDLINE SUCTION COAGULATOR Medline Industries, Inc. | GEI |
| Oct 8, 2013 | K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES Unimed Surgical Products, Inc. | GEI |
| Oct 8, 2013 | K130110 | MEDDUSA BIPOLAR SYSTEM Elliquence, LLC | GEI |
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