TPLC - Total Product Life Cycle

Premarket Reviews
Manufacturer	Decision
A-DEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED STERILIZATION PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BELIMED
	SUBSTANTIALLY EQUIVALENT	3
DEPT. OF THE ARMY
	SUBSTANTIALLY EQUIVALENT	1
GETINGE
	SUBSTANTIALLY EQUIVALENT	10
HARVARD APPARATUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
KAVO
	SUBSTANTIALLY EQUIVALENT	1
MEDILINE ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDIN CORP.
	SUBSTANTIALLY EQUIVALENT	1
MIDMARK CORP.
	SUBSTANTIALLY EQUIVALENT	7
1. K023348 MIDMARK M9 ULTRACLAVE STEAM STERILIZER
2. K090670 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
3. K900432 MODEL #M8 ELECTRONIC STERILIZER
4. K911322 MODEL #M9 ULTRACLAVE STEAM STERILIZER
5. K936181 MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
6. K990189 MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STE ...
7. K992744 MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
PRIMUS STERILIZER CO., INC.
	SUBSTANTIALLY EQUIVALENT	4
SAUTER AG
	SUBSTANTIALLY EQUIVALENT	4
SCICAN LTD.
	SUBSTANTIALLY EQUIVALENT	3
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	13
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
TUTTNAUER CO. LTD.
	SUBSTANTIALLY EQUIVALENT	6

Device Problems
Other (for use when an appropriate device code cannot be identified)	6
Loose	4
Improper or incorrect procedure or method	3
Tipover	2
Dislodged or dislocated	2
Misapplication	2
Normal	2
Detachment of device component	2
Component falling	2
Dislodged	1
Electrical issue	1
Fluid leak	1
Air leak	1
Device alarm system issue	1
Break	1
Device Cleaning Issue	1
Slippage of device or device component	1
Failure to sterilize	1
Unstable	1
Use of Device Issue	1
Water softener process, failure of	1
Misassembled	1
Mechanical issue	1
Environmental Particulates	1
No Information	1
Locking mechanism failure	1
Unknown (for use when the device problem is not known)	1
Valve(s), defective	1
Component missing	1
Device Issue	1
Malfunction	1
Total Device Problems	47