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."
1–24 of 144
Search insights Median review: 90d Cleared: 99% Top manufacturer: Datascope Corp. Lead specialty: Cardiovascular
Cleared Dec 26, 2019
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
K190884 · GDW
Datascope Corp.
General & Plastic Surgery · 266d
Cleared May 31, 2018
CARDIOSAVE Intra-Aortic Balloon Pump
K181122 · DSP
Datascope Corp.
Cardiovascular · 31d
Cleared Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
K172305 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Jan 31, 2017
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion...
K163542 · DSP
Datascope Corp.
Cardiovascular · 46d
Cleared Jul 02, 2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
K151254 · DSP
Datascope Corp.
Cardiovascular · 51d
Cleared Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...
K133074 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Feb 14, 2013
A5 ANESTHESIA DELIVERY SYSTEM
K123211 · BSZ
Datascope Corp., Patient Monitoring...
Anesthesiology · 125d
Cleared Nov 09, 2012
AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · DXC
Datascope Corp., Cardiac Assist Division
Cardiovascular · 94d
Cleared Sep 06, 2012
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
K122628 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 9d
Cleared Apr 20, 2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM)...
K120868 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 29d
Cleared Jul 15, 2009
PASSPORT V MONITOR, MODEL 0998-00-6100
K091834 · MHX
Datascope Corp., Patient Monitoring...
Cardiovascular · 23d
Cleared Jun 18, 2009
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS...
K091449 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 31d
Cleared May 08, 2009
ACCUTORR V MONITOR, MODEL 0998-00-2000
K091068 · DXN
Datascope Corp., Patient Monitoring...
Cardiovascular · 24d
Cleared Jun 09, 2008
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
K080175 · BSZ
Datascope Corp., Patient Monitoring...
Anesthesiology · 137d
Cleared Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805 · DSI
Datascope Corp.
Cardiovascular · 85d
Cleared Feb 14, 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · DXC
Datascope Corp.
Cardiovascular · 167d
Cleared Feb 05, 2007
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
K062098 · MHX
Datascope Corp.
Cardiovascular · 196d
Cleared Jan 05, 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300...
K063525 · DSP
Datascope Corp.
Cardiovascular · 44d
Cleared Nov 02, 2006
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · BZK
Datascope Corp.
Anesthesiology · 49d
Cleared Aug 12, 2005
TRIO MONITOR
K051897 · MWI
Datascope Corp.
Cardiovascular · 30d
Cleared Sep 23, 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · MSD
Datascope Corp.
Gastroenterology & Urology · 58d
Cleared Jul 23, 2004
TRIO MONITOR
K041907 · MWI
Datascope Corp.
Cardiovascular · 8d
Cleared Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · DSP
Datascope Corp.
Cardiovascular · 25d
Cleared Feb 11, 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · MWI
Datascope Corp.
Cardiovascular · 197d