Data / Medical devices / United States / ConMed Corporation
ConMed Corporation: FDA-registered device maker in Greenwood Village, CO, United States, 113 510(k) clearances
ConMed Corporation is registered with the FDA (registration 3004491689) in Greenwood Village, CO, United States. It lists 33 device types. The FDA files 113 510(k) clearances under its listings, the newest dated August 5, 2024. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004491689
- Address
- 6363 S Fiddlers Green Cir Ste 1400, Greenwood Village, CO, United States, 80111
- Owner or operator
- CONMED CORPORATION (1317214)
- Roles
- Specification developer
- First device listed
- June 27, 1992
- Registered through
- 2027
- Brand names listed
- 1 Liter Pressure Infusor, 1000 SES, 3 Liter Pressure Infusor, ABC, ABC Flex Probes, ABC Footswitch, ABC Handpieces/Accessories, ABC Laparoscopic Probe and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 113.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2024 | K240127 | PlumeSafe X5 Smoke Management System | FYD | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 20, 2023 | K230239 | AirSeal iFS System; AirSeal dV Solution | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 27, 2023 | K230547 | 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 | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 11, 2022 | K213354 | Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 19, 2021 | K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| February 19, 2021 | K202303 | CORE E3 Suction/irrigator | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 28, 2019 | K190303 | AirSeal | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 11, 2018 | K173822 | Anchor Tissue Retrieval System by CONMED | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 16, 2018 | K172516 | SurgiQuest AIRSEAL iFS System | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 18, 2017 | K172940 | ANCHOR Tissue Retrieval System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 4, 2017 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 18, 2017 | K171139 | LaparoLight Veress Needle | HIF | Substantially Equivalent | Buffalo Filter, LLC | accessdata.fda.gov |
| June 2, 2016 | K151229 | ABC D-FLEX PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 29, 2015 | K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 10, 2015 | K150569 | LaparoVue | GCJ | Substantially Equivalent | Buffalo Filter, LLC | accessdata.fda.gov |
| March 20, 2015 | K143404 | SurgiQuest AirSeal iFS System | HIF | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| February 10, 2015 | K142716 | VCARE | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 23, 2014 | K140578 | ARTHROSCOPIC ENERGY SYSTEM | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 11, 2014 | K140459 | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 10, 2014 | K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 3, 2014 | K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| February 21, 2013 | K123175 | DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 21, 2012 | K123260 | DETACHATIP III | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 12, 2012 | K120476 | MACROLYTE DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 12, 2012 | K120322 | CONMED SUREFIT DUAL DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 16, 2011 | K103375 | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Medtek Devices, Inc. | accessdata.fda.gov |
| February 16, 2011 | K103665 | CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 21, 2010 | K100686 | CONMED MACROLYTE DISPERSIVE ELECTRODE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 5, 2010 | K100180 | SURGIQUEST ANCHORPORT SIL KIT | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| March 12, 2010 | K093556 | VCARE DX | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 10, 2010 | K092414 | CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 23, 2009 | K091930 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB | GCJ | Substantially Equivalent | Anchor Products Co. | accessdata.fda.gov |
| May 5, 2009 | K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | FYD | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 7, 2007 | K073009 | ONEPORT SURGICAL TROCAR SYSTEM | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 5, 2007 | K071907 | VCARE RETRACTOR/ELEVATOR | LKF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 14, 2007 | K063859 | SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| January 25, 2007 | K062082 | CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 28, 2005 | K052009 | CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 15, 2004 | K032327 | MODERN MEDICAL BIPOLAR FORCEPS | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| April 12, 2002 | K020186 | CONMED SYSTEM 5000 ESU | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| June 8, 2000 | K000904 | PENADAPT 10 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| June 5, 2000 | K001597 | CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX | GCJ | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| September 24, 1999 | K992250 | CORE AUDIBLE TROCAR II | GCJ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| August 16, 1999 | K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| August 11, 1999 | K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| June 15, 1999 | K991855 | CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| May 17, 1999 | K990586 | CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| May 12, 1999 | K990447 | 1000 PRESSURE INFUSION SIGMACON 1000 | FRN | Substantially Equivalent | Valley West, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983623 | MODULAP | GCJ | Substantially Equivalent | Atc Technologies, Inc. | accessdata.fda.gov |
| September 8, 1998 | K982445 | MODULAP | GCJ | Substantially Equivalent | Atc Medical Technology, Inc. | accessdata.fda.gov |
| August 5, 1998 | K982309 | SMOKE EVACUATION ATTACHMENT 130XXX TBD | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| April 21, 1998 | K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | GEI | Substantially Equivalent | Aspen Laboratories, Inc. | accessdata.fda.gov |
| March 24, 1998 | K980089 | 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 | FRN | Substantially Equivalent | Valley West, Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
| July 18, 1996 | K961505 | BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| April 26, 1996 | K960562 | GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005 | GCJ | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| January 22, 1996 | K955490 | LAPAROSCOPIC KNITTER | GCJ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| October 20, 1995 | K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | GCJ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| September 29, 1995 | K954056 | UNIVERSAL PLUS ES S/I INSTRUMENT | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| July 17, 1995 | K952977 | SABRE MULTI-USE TROCAR SYSTEM | GCJ | Substantially Equivalent | Endoscopic Concepts, Inc. | accessdata.fda.gov |
| July 7, 1995 | K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| May 25, 1995 | K952204 | CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| May 5, 1995 | K950457 | CANNUAL AND TROCAR, SUPERPUBIC | HET | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| February 1, 1995 | K950170 | CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE | GCJ | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| November 15, 1994 | K943954 | ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER | HIF | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| November 7, 1994 | K943327 | CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS | GCJ | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| September 27, 1994 | K925333 | SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE | HGI | Substantially Equivalent | Aspen Labs | accessdata.fda.gov |
| September 1, 1994 | K943542 | ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| July 28, 1994 | K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | GCJ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| July 13, 1994 | K942892 | CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| May 24, 1994 | K942215 | CONMED ELECTROSURGICAL GROUNDING PADS | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| May 12, 1994 | K933497 | LAPAROSCOPIC COVERED SURGICAL RETRACTOR | GCJ | Substantially Equivalent | Advanced Surgical, Inc. | accessdata.fda.gov |
| March 28, 1994 | K940439 | GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT | GCJ | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| March 28, 1994 | K931215 | HAND-TROL S | DWG | Substantially Equivalent | Aspen Labs | accessdata.fda.gov |
| March 24, 1994 | K931879 | REFLEX HTR | GCJ | Substantially Equivalent | Richard-Allan Medical Ind., Inc. | accessdata.fda.gov |
| March 7, 1994 | K934828 | CONMED UNIVERSAL PLUS | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 22, 1994 | K924200 | REFLEX(R) ESC | KNF | Substantially Equivalent | Richard-Allan Medical Ind., Inc. | accessdata.fda.gov |
| January 11, 1994 | K932021 | ENTREE CANNULA FASCIA ANCHORS | FBM | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| January 11, 1994 | K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER | HET | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| November 30, 1993 | K930067 | BUFFALO FILTER SURGICAL MASK | FXX | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| November 30, 1993 | K930062 | BUFFALO FILTER REPLACEMENT FILTER #BST300UL | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| November 12, 1993 | K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | GBW | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| November 3, 1993 | K930041 | VICROSAFE 6 AND VICROSAFE 12 | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| November 2, 1993 | K930061 | BUFFALO FILTER REPLACEMENT FILTER BST312PF | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| September 23, 1993 | K933332 | MODEL 6400 ABC ELECTROSURGERY GENERATOR | GEI | Substantially Equivalent | William E. Mckay | accessdata.fda.gov |
| September 13, 1993 | K924732 | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Buffalo Filter Co., Inc. | accessdata.fda.gov |
| July 28, 1993 | K932022 | ENTREE THORACOSCOPY CANNULA SET | GCJ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| July 23, 1993 | K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | GAZ | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| July 21, 1993 | K924929 | REFLEX(R) ECA | HBT | Substantially Equivalent | Richard-Allan Medical | accessdata.fda.gov |
| April 20, 1993 | K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | GCJ | Substantially Equivalent | Richard-Allan Medical Ind., Inc. | accessdata.fda.gov |
| April 7, 1993 | K924283 | MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | Microsurge, Inc. | accessdata.fda.gov |
| December 30, 1992 | K925903 | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION | GEI | Substantially Equivalent | Birtcher Medical Systems, Inc. | accessdata.fda.gov |
| December 24, 1992 | K922435 | LAPAROSCOPIC CURVED TRIANGLE RETRACTOR | GCJ | Substantially Equivalent | Advanced Surgical, Inc. | accessdata.fda.gov |
| August 17, 1992 | K921921 | CATHETER CHOLANGIOGRAPHY | GEI | Substantially Equivalent | Laparomed Corp. | accessdata.fda.gov |
| February 13, 1992 | K913213 | SINGLE USE LEE ELECTRODE | HGI | Substantially Equivalent | Aspen Laboratories, Inc. | accessdata.fda.gov |
| November 27, 1991 | K914426 | ENTREE NEEDLE | FHO | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
| November 1, 1991 | K911865 | NORTEC CONNECTING TUBE SET | GAZ | Substantially Equivalent | North American Sterilization & Packaging Co. | accessdata.fda.gov |
| August 29, 1991 | K910889 | ABC LAPAROSCOPIC HANDPROBE | GEI | Substantially Equivalent | Birtcher Medical Systems, Inc. | accessdata.fda.gov |
| July 19, 1991 | K911813 | ENTREE CANNULA | FBM | Substantially Equivalent | Core Dynamics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 7, 2012 | 61821 | Not yet classified | Terminated | Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handp | The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding. | accessdata.fda.gov |
| May 7, 2012 | 61814 | Not yet classified | Terminated | Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source an | An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery. | accessdata.fda.gov |
| December 27, 2010 | 57544 | Not yet classified | Terminated | ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. | accessdata.fda.gov |
| March 29, 2010 | 55189 | Not yet classified | Terminated | ConMed Goldline Hand Controlled With Needle Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130301A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502. | Electrosurgical pencil may remain activated or self activate after power switch is released. | accessdata.fda.gov |
| September 30, 2009 | 53545 | Not yet classified | Terminated | (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UT | One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization. | accessdata.fda.gov |
| December 18, 2008 | 52030 | Not yet classified | Terminated | ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (pouch label) ABC Bend-A-Beam Handpiece REF 134003 Han | The internal electrode protrudes in front of the ceramic insulator at the tip of the handpiece. | accessdata.fda.gov |
| November 2, 2007 | 45867 | Not yet classified | Terminated | Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 13910 | Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal | accessdata.fda.gov |
| September 5, 2006 | 36253 | Not yet classified | Terminated | Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Conmed Corporation | Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy. | accessdata.fda.gov |
| September 15, 2003 | 27659 | Not yet classified | Terminated | Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230. | The Hyfrecator 2000 units were released without documented adherence to their voltage output specification. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Exhaust, Surgical
- All makers of Mask, Surgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Clip, Removable (Skin)
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Insufflator, Laparoscopic
Updated August 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.