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."
97–109 of 109
Search insights Median review: 84d Cleared: 100% Top manufacturer: Scimed Life Systems, Inc. Lead specialty: Cardiovascular
Cleared Jan 08, 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Oct 23, 1984
SCIMED PM200 INFLATION MANOMETER
K843448 · MAV
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Oct 23, 1984
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 162d
Cleared Apr 24, 1984
SCIMED MODEL SC4000
K840610 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Jun 30, 1983
MODEL TP THERMISTOR PROBE
K831528 · DRF
Scimed Life Systems, Inc.
Cardiovascular · 49d
Cleared Jun 03, 1983
SCI MED TUBING CONNECTORS
K831261 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Jun 03, 1983
SCI MED TEMPERATURE MONITORING ADAPTOR
K831260 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared May 24, 1982
SCIMED MODEL SC 3000
K820954 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared May 18, 1982
SC-2500F CARDIOTOMY RESERVIOR
K813268 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 179d
Cleared Dec 07, 1979
SCI MED PERICARDIAL SUBSTITUTE
K791792 · DXZ
Scimed Life Systems, Inc.
Cardiovascular · 85d
Cleared Mar 02, 1978
HEAT EXCHANGER, DISP., OMNITHERM
K772117 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 114d
Cleared Apr 26, 1977
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681 · KRI
Scimed Life Systems, Inc.
Cardiovascular · 15d