Data / Medical devices / United States / Conmed Corporation
Conmed Corporation: FDA-registered device maker in Westborough, MA, United States, 63 510(k) clearances and 1 PMA approval
Conmed Corporation is registered with the FDA (registration 1223925) in Westborough, MA, United States. It lists 42 device types. The FDA files 63 510(k) clearances and 1 PMA approval under its listings, the newest dated August 26, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1223925
- FEI number
- 1000305720
- Address
- 134 Flanders Rd, Westborough, MA, United States, 01581
- Owner or operator
- CONMED CORPORATION (1317214)
- Roles
- Specification developer
- First device listed
- June 27, 1992
- Registered through
- 2026
- Brand names listed
- Adult Arm Support with Cover, Airsoft Patient Positioner, American Dilation System, Apollo Papillotomes, Axcess Papillotomes, BRAINSTREAM Disposable Deep Cup EEG Electrodes, Backpads Strippers, Beamer 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2022 | K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 28, 2022 | K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 1, 2020 | K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | GXY | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| August 7, 2013 | K131642 | RSH BILIARY STONE REMOVAL DEVICE | LQR | Substantially Equivalent | Rsh, LLC | accessdata.fda.gov |
| August 7, 2009 | K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | DRX | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 10, 2008 | K081644 | BEAMER ARGON PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 19, 2008 | K081580 | BEAMER ARGON SNARE PROBE | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 21, 2006 | K061606 | DEFIBRILLATOR CABLE TESTER, MODEL DT2200 | DRG | Substantially Equivalent | Medical Devices/Padpro, Inc. | accessdata.fda.gov |
| April 28, 2006 | K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM | KNT | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| July 14, 2005 | K050992 | CONMED IRRIGATION NOZZLE | KPL | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| January 14, 2004 | K033936 | BARD ELIMINATOR PET BALLOON DILATORS | KNQ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 28, 2002 | K020743 | PADPRO, MODEL 2502 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| May 8, 2002 | K020203 | PADPRO MODEL #2516 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| February 27, 2002 | K020288 | PADPRO, MODEL 2603 | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| January 18, 2002 | K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| September 4, 2001 | K003548 | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS | MKJ | Substantially Equivalent | Padpro, LLC | accessdata.fda.gov |
| February 5, 2001 | K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | MKJ | Substantially Equivalent | Medical Devices, Inc. | accessdata.fda.gov |
| June 7, 2000 | K001159 | HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| March 1, 2000 | K992524 | PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES | DSA | Substantially Equivalent | Advantage Medical Electronics, Inc. | accessdata.fda.gov |
| November 26, 1999 | K991105 | ECG ELECTRODE (VARIOUS) | DRX | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| September 10, 1998 | K982557 | BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES | KNS | Substantially Equivalent | Bard Interventional Products Div. | accessdata.fda.gov |
| October 16, 1997 | K971137 | BARD RAPIDFIRE MULTIPLE BAND LIGATOR | MND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 30, 1997 | K970493 | HYFRECATOR 2000 | GEI | Substantially Equivalent | Aspen Labs | accessdata.fda.gov |
| March 24, 1997 | K964844 | CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS | FPA | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| March 11, 1997 | K963787 | EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM | DRX | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| December 11, 1996 | K964469 | 700-F SERIES STIMULATION ELECTRODES | LDD | Substantially Equivalent | Cardiotronics Systems, Inc. | accessdata.fda.gov |
| September 13, 1996 | K963088 | SHEATH, ELECTROSURGICAL PENCIL | GEI | Substantially Equivalent | Aspen Laboratories, Inc. | accessdata.fda.gov |
| April 9, 1996 | K960264 | CONMED EKG STRIPPER | DRX | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| June 20, 1995 | K945836 | 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES | DRX | Substantially Equivalent | Conmed Andover Medical, Inc. | accessdata.fda.gov |
| March 24, 1995 | K950065 | CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS | MGP | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 16, 1995 | K946293 | MILL-ROSE SCOPE CLEANING BRUSH | MNL | Substantially Equivalent | Mill-Rose Laboratory | accessdata.fda.gov |
| December 22, 1994 | K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | GEI | Substantially Equivalent | Birtcher Medical Systems, Inc. | accessdata.fda.gov |
| November 28, 1994 | K940661 | STIEGMANN-GOFF ENDOSCOPIC LIGATOR | MND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 22, 1994 | K944650 | WANG BRONCHIAL NEEDLE BRUSH | EOQ | Substantially Equivalent | Mill-Rose Laboratory | accessdata.fda.gov |
| October 27, 1994 | K945034 | CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES | DSA | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| September 22, 1994 | K942718 | CLOTH TENS/BNES ELECTRODE | GXY | Substantially Equivalent | Conmed Andover Medical, Inc. | accessdata.fda.gov |
| March 7, 1994 | K935389 | CONMED VENI-GARD I.V. DRESSING | KMK | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| February 18, 1994 | K933649 | CONMED ECG PATIENT CABLES AND LEADWIRES | DSA | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
| November 23, 1993 | K931457 | NDM SILVON ECG ELECTRODES | DRX | Substantially Equivalent | Ndm Acquisition Corp. | accessdata.fda.gov |
| May 12, 1993 | K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | NAE | Substantially Equivalent | Ndm Corp. | accessdata.fda.gov |
| November 24, 1992 | K920361 | BARD BILIARY BALLOON DILATORS | FGE | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 10, 1991 | K914181 | WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE | EOQ | Substantially Equivalent | Mill-Rose Laboratory | accessdata.fda.gov |
| August 16, 1991 | K912415 | MEDICAL SAFETY CABLE AND LEAD SYSTEM | BZQ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 22, 1991 | K910494 | RESTING EKG ELECTRODE SERIES | DRX | Substantially Equivalent | Medtronic Andover Medical, Inc. | accessdata.fda.gov |
| April 16, 1991 | K905498 | STAT 2 IV PUMPETTE | LDR | Substantially Equivalent | The Master Medical Corp. | accessdata.fda.gov |
| March 19, 1991 | K905088 | HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | Esco Precision, Inc. | accessdata.fda.gov |
| February 5, 1991 | K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE | DRX | Substantially Equivalent | Medtronic Andover Medical, Inc. | accessdata.fda.gov |
| July 18, 1990 | K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE | DRX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 15, 1989 | K890201 | RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 | DRX | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| December 24, 1985 | K854864 | BI-POLAR FORCEPS | GEI | Substantially Equivalent | Birtcher Corp. | accessdata.fda.gov |
| October 17, 1985 | K853274 | AMERICAN DILATATION SYSTEM | KNQ | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| April 25, 1984 | K833491 | ENDO BITE BLOCK | KTI | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| June 25, 1982 | K821697 | INJECTION ASPIRATING NEEDLES | GAA | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| May 3, 1982 | K820771 | MICROBIOLOGY SPECIMEN BRUSH | BTG | Substantially Equivalent | Mill-Rose Laboratory | accessdata.fda.gov |
| April 9, 1982 | K820431 | E.R.C.P. CANNULAS | ODD | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| April 8, 1982 | K820430 | DIATHERMIC SNARES | KNS | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| March 5, 1982 | K820259 | STERILE CYTOLOGY BRUSHES | GEE | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
| March 4, 1981 | K810273 | DAVOL ELECTRO MEDICAL SYSTEMS | GEI | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 2, 1980 | K800617 | HYFRECATOR, #733 | GEI | Substantially Equivalent | Birtcher Corp. | accessdata.fda.gov |
| October 1, 1979 | K791668 | ENDOSCOPIC CYTOLOGY BRUSHES | FDX | Substantially Equivalent | Mill-Rose Laboratory | accessdata.fda.gov |
| June 2, 1978 | K780724 | BUBBLE SUCTION TUBING | BYY | Substantially Equivalent | Davol, Inc. | accessdata.fda.gov |
| January 5, 1977 | K761301 | V-TRACE ECG BACKPAD | DRX | Substantially Equivalent | Ndm Corp. | accessdata.fda.gov |
| August 23, 1976 | K760280 | ELECTRODE SERIES 1401 | DRX | Substantially Equivalent | Andover Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2021 | P200004 | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters | MKJ | 1 | June 16, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 5, 2007 | 37793 | Not yet classified | Terminated | Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190) | Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure | accessdata.fda.gov |
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Updated August 26, 2022. 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.