FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

892 results for "Boston Scientific"
817–840 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Nov 23, 1992
TRELEX MESH
K924749 · FTL
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 62d
Cleared Nov 18, 1992
BALLOON DILATATION CATHETER
K922610 · LIT
Boston Scientific Corp
Cardiovascular · 169d
Cleared Nov 10, 1992
SHORT TEGWIRE -- MODIFIED
K924276 · LIT
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 09, 1992
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · ITX
Boston Scientific Corp
Radiology · 438d
Cleared Nov 02, 1992
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER
K924047 · LIT
Boston Scientific Corp
Cardiovascular · 83d
Cleared Sep 01, 1992
MEADOX SURGIMED BIOPSY GUN III
K922879 · KNW
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 78d
Cleared Aug 14, 1992
DOWD(TM) II
K922349 · KOE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Aug 12, 1992
CATHETER INTRODUCER
K920528 · DYB
Boston Scientific Corp
Cardiovascular · 189d
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 25, 1991
COHERENT HOLMIUM:YAG SURGICAL LASER
K910037 · GEX
Coherent Medical Group
General & Plastic Surgery · 264d
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 May 31, 1991
SURGICA(TM) H
K910898 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 88d
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