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."
49–72 of 109
Search insights Median review: 84d Cleared: 100% Top manufacturer: Scimed Life Systems, Inc. Lead specialty: Cardiovascular
Cleared May 24, 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared May 12, 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 238d
Cleared May 06, 1994
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
K940545 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Apr 19, 1994
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Mar 31, 1994
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared Mar 10, 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 22, 1994
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Feb 14, 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Jan 18, 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 131d
Cleared Jan 14, 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Dec 15, 1993
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 197d
Cleared Dec 08, 1993
SCIMED MAVERICK PTA CATHETER
K932537 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 196d
Cleared Sep 09, 1993
SCIMED VIPER
K933183 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Aug 17, 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 11, 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Jun 25, 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jun 16, 1993
SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
K925608 · MFY
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared May 20, 1993
MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT
K925945 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 177d
Cleared Apr 08, 1993
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 105d
Cleared Feb 12, 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 225d
Cleared Jan 11, 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared Oct 22, 1992
PARAMETRIC PROCESS CONTROL
K923826 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 84d
Cleared Oct 16, 1992
SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER
K921577 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 197d