Panels › Physical Medicine › Product code LHC · Class 1
Warmer, Irrigation Solution
Regulation 890.5950
0510(k)s in 12 months (24 all time)
0recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in LHC
| Company | 510(k)s | Recalls |
|---|---|---|
| Resource Optimization & Innovation Llc | 0 | 8 |
| Ecolab, Inc. | 4 | 1 |
| O.R. Solutions, Inc. | 4 | 0 |
| C Change Surgical, LLC | 2 | 0 |
| American Hydro-Surgical Instruments, Inc. | 1 | 0 |
| Augustine Medical, Inc. | 1 | 0 |
| Cabot Medical Corp. | 1 | 0 |
| Getinge Sourcing, LLC | 1 | 0 |
| Johnson Flexgroup | 1 | 0 |
| Kmi Kolster Methods, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 7, 2016 | K153713 | Getinge Series Warming Cabinet Getinge Sourcing, LLC | LHC |
| Jan 15, 2016 | K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes Ecolab, Inc. | LHC |
| Feb 26, 2015 | K150190 | IntraTemp Solution Warmer Ecolab, Inc. | LHC |
| Dec 30, 2014 | K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE Ecolab, Inc. | LHC |
| Aug 28, 2014 | K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED Ecolab, Inc. | LHC |
| Jan 13, 2009 | K083417 | INTRATEMP SOLUTION WARMER C Change Surgical, LLC | LHC |
| Jun 13, 2008 | K080609 | SWC/DWC WARMING CABINETS Mac Medical | LHC |
| Aug 15, 2005 | K051819 | C CHANGE SOLUTION WARMER C Change Surgical, LLC | LHC |
| Nov 13, 2002 | K023283 | 1075LD HUSH-SLUSH O.R. Solutions, Inc. | LHC |
| Nov 13, 2002 | K023282 | ORS-3000LD O.R. Solutions, Inc. | LHC |
| Jun 27, 2002 | K021288 | ORS-1000LD O.R. Solutions, Inc. | LHC |
| Jun 26, 2002 | K021289 | WARMER 2000LD O.R. Solutions, Inc. | LHC |
| Nov 16, 2000 | K002859 | SSW-STERILE SOLUTION WARMER Kmi Kolster Methods, Inc. | LHC |
| Oct 16, 1998 | K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM Princeton Regulatory Assoc. | LHC |
| Aug 22, 1997 | K971117 | WARMETTE Olympic Medical Corp. | LHC |
| Jun 20, 1995 | K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM American Hydro-Surgical Instruments, Inc. | LHC |
| Feb 22, 1994 | K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS Cabot Medical Corp. | LHC |
| Jan 28, 1994 | K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM Augustine Medical, Inc. | LHC |
| Jun 2, 1992 | K921633 | ORS-2000 SERIES Mnlase, Inc. | LHC |
| May 20, 1988 | K880876 | C-STAT/1000 Sonne Medical, Inc. | LHC |
| Feb 10, 1988 | K880252 | THERMAL-PAK MODEL SW 1000 Micro Tek Engineering | LHC |
| Jan 25, 1984 | K833944 | STERILE SOLUTION WARMER National Fabtronix, Inc. | LHC |
| Nov 21, 1983 | K832642 | ALPHA-I Johnson Flexgroup | LHC |
| Jul 1, 1981 | K811524 | AQUACADE Respiratory Care, Inc. | LHC |
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