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 |
|---|---|---|---|
| Dec 16, 2008 | K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Dec 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Dec 10, 2008 | K082902 | RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES Rz Medizintechnik GmbH, NL | GEI |
| Dec 9, 2008 | K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 Gyrus Acmi, Inc. | GEI |
| Dec 4, 2008 | K082962 | TIVAMED COOLED RF SYSTEM, MODEL 78001 Tivamed, Inc. | GEI |
| Dec 3, 2008 | K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES Peak Surgical, Inc. | GEI |
| Nov 17, 2008 | K082568 | SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE Bovie Medical | GEI |
| Nov 5, 2008 | K082980 | ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Oct 31, 2008 | K081312 | ARAGON ONESHOT SYSTEM Aragon Surgical, Inc. | GEI |
| Oct 21, 2008 | K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Oct 17, 2008 | K082954 | ENCAGE BIPOLAR RF PROBE Trod Medical SA, FR | GEI |
| Oct 15, 2008 | K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 Vnus Medical Technologies, Inc. | GEI |
| Oct 15, 2008 | K082666 | ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS Arthrocare Corp. | GEI |
| Oct 8, 2008 | K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B Barrx Medical, Incorporated | GEI |
| Oct 2, 2008 | K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR Bovie Medical | GEI |
| Sep 29, 2008 | K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 National Advanced Endoscopy Devices, Inc. | GEI |
| Sep 25, 2008 | K081503 | AED MONOPOLAR LAP ACCESSORIES National Advanced Endoscopy Devices, Inc. | GEI |
| Sep 19, 2008 | K073498 | LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM Rudolf Medical GmbH + Co. KG, DE | GEI |
| Sep 10, 2008 | K081644 | BEAMER ARGON PROBE Conmed Corporation | GEI |
| Aug 28, 2008 | K082323 | ARTHROCARE ARTHROWANDS Arthrocare Corp. | GEI |
| Aug 28, 2008 | K081559 | GENESIS Medisiss | GEI |
| Aug 22, 2008 | K082197 | RHYTEC, INC., PORTRAIT PSR Rhytec Incorporated | GEI |
| Aug 12, 2008 | K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS Xodus Medical, Inc. | GEI |
| Aug 8, 2008 | K081766 | PKS OMNI INSTRUMENT Gyrus-Acmi L.P. | GEI |
| Aug 6, 2008 | K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 Gyrus Acmi, Inc. | GEI |
| Jul 31, 2008 | K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE Gyrus Acmi, Inc. | GEI |
| Jul 30, 2008 | K071759 | LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) Live Tissue Connect, Inc. | GEI |
| Jul 29, 2008 | K081678 | CONMED BEAMER SYSTEM C600 Kls Martin GmbH + Co. KG, DE | GEI |
| Jul 28, 2008 | K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL Surgrx, Inc. | GEI |
| Jul 24, 2008 | K081431 | MEG LAPAROSCOPIC ELECTRODES Bovie Medical | GEI |
| Jul 23, 2008 | K073616 | FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE Electromedics Co. , Ltd. | GEI |
| Jul 22, 2008 | K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 Peak Surgical, Inc. | GEI |
| Jul 3, 2008 | K080451 | UNIBLATE ELECTROSURGICAL DEVICE AngioDynamics, Inc. | GEI |
| Jul 3, 2008 | K080287 | ONCOBIONIC BIPOLAR ELECTRODE AngioDynamics, Inc. | GEI |
| Jun 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL Conmed Corporation | GEI |
| Jun 24, 2008 | K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM Plasma Surgical, Ltd., GB | GEI |
| Jun 19, 2008 | K081580 | BEAMER ARGON SNARE PROBE Conmed Corporation | GEI |
| May 9, 2008 | K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS Olsen Medical | GEI |
| May 8, 2008 | K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 Celon AG Medical Instruments | GEI |
| May 2, 2008 | K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK Gyrus Acmi, Inc. | GEI |
| Apr 10, 2008 | K072041 | BOVIE IDS-400 ELECTROSURGICAL GENERATOR Bovie Medical | GEI |
| Apr 2, 2008 | K080715 | ERBE VIO ESU, MODEL VIO 200 S Erbe USA, Inc. | GEI |
| Apr 2, 2008 | K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS Barrx Medical, Incorporated | GEI |
| Mar 31, 2008 | K080610 | ARTHROCARE ORTHOWAND SURGICAL DEVICE Arthrocare Corp. | GEI |
| Mar 27, 2008 | K080717 | HABIB HEXABLATE 10 Emcision , Ltd., GB | GEI |
| Mar 27, 2008 | K073111 | PORTRAIT PSR, MODEL 745915 Rhytec Incorporated | GEI |
| Mar 25, 2008 | K073455 | E-VAC New Leaf Medical, Inc. | GEI |
| Mar 20, 2008 | K080482 | ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 Arthrocare Corp. | GEI |
| Mar 17, 2008 | K073450 | SUTTER ELECTROSURGICAL CABLES Sutter Medizintechnik GmbH | GEI |
| Feb 28, 2008 | K080145 | PRIMAEVA MEDICAL SYSTEM Primaeva Medical, Inc. | GEI |
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