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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

144 results for "Datascope Corp."
25–48 of 144
Search insights Median review: 90d Cleared: 99% Top manufacturer: Datascope Corp. Lead specialty: Cardiovascular
Cleared Oct 10, 2003
VIEWPOINT TELEMETRY SYSTEM
K031760 · MHX
Datascope Corp.
Cardiovascular · 126d
Cleared Sep 09, 2003
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
K031849 · MHX
Datascope Corp.
Cardiovascular · 85d
Cleared Aug 11, 2003
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · DSP
Datascope Corp.
Cardiovascular · 76d
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · DSP
Datascope Corp.
Cardiovascular · 21d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550 · DSI
Datascope Corp.
Cardiovascular · 190d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared Feb 06, 2002
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
K011540 · MHX
Datascope Corp.
Cardiovascular · 264d
Cleared Nov 02, 2001
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC,...
K013326 · DSP
Datascope Corp.
Cardiovascular · 28d
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB,...
K003598 · DSP
Datascope Corp.
Cardiovascular · 30d
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · DSP
Datascope Corp.
Cardiovascular · 29d
Cleared Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · DYB
Datascope Corp.
Cardiovascular · 22d
Cleared May 12, 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER...
K001198 · DQX
Datascope Corp.
Cardiovascular · 29d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
K994157 · DSP
Datascope Corp.
Cardiovascular · 95d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · DSI
Datascope Corp.
Cardiovascular · 87d
Cleared May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · DXN
Datascope Corp.
Cardiovascular · 212d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · DRT
Datascope Corp.
Cardiovascular · 232d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...
K980780 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
K980385 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared Mar 13, 1998
GAS MODULE II, MODEL 0998-00-0143
K974903 · CBS
Datascope Corp.
Anesthesiology · 72d
Cleared Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · DYB
Datascope Corp.
Cardiovascular · 85d
Cleared Sep 25, 1997
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
K970061 · DQA
Datascope Corp.
Anesthesiology · 261d
Cleared Jul 01, 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · DSP
Datascope Corp.
Cardiovascular · 182d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
K964987 · DSP
Datascope Corp.
Cardiovascular · 94d
Cleared Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · DSP
Datascope Corp.
Cardiovascular · 210d