Skytron, Div. The KMW Group, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1309-2022 | Class II | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A | June 2, 2022 |
| Z-1861-2021 | Class II | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for | May 11, 2021 |
| Z-0071-2021 | Class II | VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Li | September 11, 2020 |
| Z-0109-2021 | Class II | SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, | March 10, 2020 |
| Z-1569-2020 | Class II | Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. sc | March 5, 2020 |
| Z-1779-2019 | Class II | Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYT | April 18, 2019 |
| Z-1844-2016 | Class II | EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General | April 6, 2016 |
| Z-1871-2016 | Class II | Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27 | March 28, 2016 |
| Z-0655-2016 | Class II | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utiliz | December 2, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | July 6, 2007 |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | November 13, 2002 |
| K002463 | STELLAR | November 8, 2000 |
| K992090 | MILLENNIUM GOLD | September 8, 1999 |
| K950192 | SKYTRON SKYBOOM SERIES | April 3, 1995 |
| K940616 | SKYTRON ELITE 3500 TABLE | June 13, 1994 |
| K933564 | SKYTRON EXAM LIGHT | February 10, 1994 |
| K926045 | SKYTRON LIFE ISLAND 21 | July 27, 1993 |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | February 20, 1992 |
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | September 4, 1990 |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | March 19, 1990 |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | February 20, 1990 |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | September 24, 1987 |
| K870045 | SKYTRON MODEL 610-2 | February 4, 1987 |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | September 12, 1985 |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | September 5, 1985 |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | May 17, 1985 |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | May 17, 1985 |
| K811311 | SKYTRON ELITE SURGICAL TABLES | June 2, 1981 |