Medical Device Manufacturer · US , Plymouth , MN

Sterilmed, Inc. - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 2001
64
Total
64
Cleared
0
Denied
64 devices
26-50 of 64
Cleared Jan 14, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · NLH
Cardiovascular · 182d
Cleared Nov 03, 2009
REPROCESSED PULSE OXIMETER SENSORS
K092368 · NLF
Anesthesiology · 90d
Cleared Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · KTT
Orthopedic · 83d
Cleared Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
K083060 · NLQ
General & Plastic Surgery · 87d
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814 · ERL
Ear, Nose, Throat · 174d
Cleared Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · KTT
Orthopedic · 74d
Cleared Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342 · KTT
Orthopedic · 92d
Cleared Feb 12, 2008
REPROCESSED SCISSOR TIPS
K073613 · NUJ
General & Plastic Surgery · 53d
Cleared Oct 18, 2007
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
K070930 · NLL
General & Plastic Surgery · 198d
Cleared Sep 12, 2007
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
K070859 · NLL
General & Plastic Surgery · 168d
Cleared Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
K063844 · NQG
Cardiovascular · 79d
Cleared May 23, 2006
REPROCESSED ENDOSCOPIC TROCAR
K052299 · NLM
Gastroenterology & Urology · 272d
Cleared May 04, 2006
REPROCESSED BALOON INFLATION DEVICE
K053188 · NKU
Cardiovascular · 170d
Cleared Jul 20, 2005
REPROCESSED COLD BIOPSY FORCEPS
K042648 · NON
Gastroenterology & Urology · 295d
Cleared Jul 20, 2005
REPROCESSED HOT BIOPSY FORCEPS
K050136 · NLU
Gastroenterology & Urology · 180d
Cleared Jun 14, 2005
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K051220 · NLH
Cardiovascular · 33d
Cleared May 23, 2005
REPROCESSED ENDOSCOPIC TROCAR
K043592 · NLM
Gastroenterology & Urology · 145d
Cleared Apr 12, 2005
REPROCESSED HARMONIC SCALPELS
K050343 · NLQ
General & Plastic Surgery · 60d
Cleared Mar 01, 2005
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · OWQ
Cardiovascular · 76d
Cleared Mar 01, 2005
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
K043513 · NLH
Cardiovascular · 71d
Cleared Sep 23, 2004
MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS
K041127 · NLF
Anesthesiology · 146d
Cleared Mar 28, 2003
REPROCESSED PULSE OXIMETER SENSORS
K012677 · NLF
Anesthesiology · 591d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · OWQ
Cardiovascular · 430d
Cleared Aug 14, 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · NLH
Cardiovascular · 373d
Cleared Aug 14, 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · NLH
Cardiovascular · 365d
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