Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

109 results for "Scimed Life Systems, Inc."
1–24 of 109
Search insights Median review: 84d Cleared: 100% Top manufacturer: Scimed Life Systems, Inc. Lead specialty: Cardiovascular
Cleared Nov 12, 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 365d
Cleared Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Apr 29, 1998
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
K980360 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Feb 19, 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 65d
Cleared Jan 12, 1998
LUGE GUIDE WIRE
K973945 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jun 03, 1997
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
K970823 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 89d
Cleared May 21, 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE...
K964551 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared Mar 28, 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 65d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Dec 17, 1996
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
K962572 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 169d
Cleared Jul 03, 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared May 15, 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 42d
Cleared May 15, 1996
SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
K961015 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared Apr 29, 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 73d
Cleared Apr 29, 1996
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Mar 22, 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · MAV
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Feb 23, 1996
SCIMED DISPATCH CORONARY INFUSION CATHETER
K953133 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 232d
Cleared Jan 16, 1996
SCIMED ANGIOGRAPHIC KITS
K953265 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 187d
Cleared Sep 19, 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 55d
Cleared Jul 27, 1995
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Jul 21, 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · DXT
Scimed Life Systems, Inc.
Cardiovascular · 93d
Cleared Jun 22, 1995
SCIMED EXPO ANGIOGRAPHIC CATHETER
K951720 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 69d