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."
73–96 of 109
Search insights Median review: 84d Cleared: 100% Top manufacturer: Scimed Life Systems, Inc. Lead specialty: Cardiovascular
Cleared Oct 06, 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared Jul 23, 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 63d
Cleared Jun 09, 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 265d
Cleared Nov 22, 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 57d
Cleared Nov 22, 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Aug 30, 1991
SCIMED 7 FR. & 8 FR.
K913364 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 32d
Cleared Aug 12, 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 108d
Cleared Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 66d
Cleared Feb 07, 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 24d
Cleared Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 293d
Cleared Jan 09, 1990
THE PILOT SCIMED TORQUE DEVICE
K896108 · LOX
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Sep 21, 1989
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
K894103 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Apr 03, 1989
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 119d
Cleared Sep 26, 1988
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 26, 1988
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
K883053 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 86d
Cleared Feb 29, 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Nov 25, 1986
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Sep 23, 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 53d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Apr 10, 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 91d