FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

881 results for "boston scientific"
817–840 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jul 24, 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302 · DQX
Boston Scientific Corp
Cardiovascular · 70d
Cleared Jul 01, 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 121d
Cleared May 06, 1992
ULTRA-THIN
K920547 · LIT
Boston Scientific Corp
Cardiovascular · 90d
Cleared Dec 20, 1991
CATHETER, URETERAL DILATOR
K914617 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 64d
Cleared Dec 18, 1991
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K904556 · IOL
Boston Scientific Corp
Physical Medicine · 439d
Cleared Nov 25, 1991
FLOSWITCH(R) HP
K913871 · DQO
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 05, 1991
TEGWIRE (TM)
K913391 · LIT
Boston Scientific Corp
Cardiovascular · 98d
Cleared Oct 16, 1991
SUB-4(TM), PERIPHERAL DILATATION CATHETER
K913689 · LIT
Boston Scientific Corp
Cardiovascular · 58d
Cleared Sep 23, 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 90d
Cleared Aug 29, 1991
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER
K912792 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 65d
Cleared Aug 20, 1991
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 581d
Cleared Apr 09, 1991
TEGWIRE (TM)
K911203 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Apr 09, 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · LIT
Boston Scientific Corp
Cardiovascular · 39d
Cleared Apr 08, 1991
SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65
K910051 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Apr 02, 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Mar 25, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 180d
Cleared Mar 25, 1991
OWENS CATHETER
K896520 · LIT
Boston Scientific Corp
Cardiovascular · 495d
Cleared Mar 11, 1991
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 94d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788 · DQO
Boston Scientific Corp
Cardiovascular · 55d
Cleared Dec 03, 1990
INFLATION/DEFLATION DEVICE
K904394 · MAV
Boston Scientific Corp
Cardiovascular · 69d
Cleared Nov 08, 1990
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · DTK
Boston Scientific Corp
Cardiovascular · 212d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 79d
Cleared Oct 31, 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · LIT
Boston Scientific Corp
Cardiovascular · 296d
Cleared Oct 16, 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · LIT
Boston Scientific Corp
Cardiovascular · 299d