Baylis Medical Co., Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 28
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT | January 24, 2013 |
| K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM | March 13, 2012 |
| K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH | April 1, 2011 |
| K102192 | INDISCAL DIGITAL MANOMETER | February 23, 2011 |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | August 10, 2010 |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | July 28, 2010 |
| K101117 | LEV-OR DILATION CATHETER OTW | July 16, 2010 |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | November 17, 2009 |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS | October 16, 2009 |
| K073326 | NRG TRANSSEPTAL NEEDLE | May 28, 2008 |
| K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD | December 19, 2007 |
| K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | July 19, 2007 |
| K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PP | January 8, 2007 |
| K051670 | RF TUNNELER WIRE | March 30, 2006 |
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | November 30, 2005 |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | December 10, 2003 |
| K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 | September 11, 2003 |
| K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD | July 17, 2003 |
| K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 | December 31, 2002 |
| K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) | May 3, 2002 |