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"
769–792 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jul 07, 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · KNY
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jun 17, 1994
PLATINUM PLUS GUIDEWIRE
K935997 · DQX
Boston Scientific Corp
Cardiovascular · 184d
Cleared Jun 10, 1994
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER
K935292 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared Jun 02, 1994
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
K934116 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 281d
Cleared May 16, 1994
MICROVASIVE MAXFORCE
K934697 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 228d
Cleared Mar 15, 1994
PROTECTOR INTRODUCER SHEATH
K930808 · DYB
Boston Scientific /International...
Cardiovascular · 392d
Cleared Mar 14, 1994
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
K935814 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared Mar 07, 1994
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
K936226 · KDC
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 68d
Cleared Feb 14, 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Feb 10, 1994
GUIDING CATHETER
K930476 · DQY
Boston Scientific Corp
Cardiovascular · 377d
Cleared Feb 01, 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 225d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334 · DQX
Boston Scientific Corp
Cardiovascular · 202d
Cleared Jan 26, 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 502d
Cleared Jan 07, 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 119d
Cleared Jan 03, 1994
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
K933020 · EYB
Boston Scientific Corp
Gastroenterology & Urology · 195d
Cleared Dec 09, 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · LIT
Boston Scientific Corp
Cardiovascular · 105d
Cleared Nov 22, 1993
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · GEX
Boston Scientific Corp
General & Plastic Surgery · 115d
Cleared Nov 12, 1993
MICROWAVE INSURG INTRODUCER
K933985 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 88d
Cleared Nov 10, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · LIT
Boston Scientific Corp
Cardiovascular · 440d
Cleared Nov 04, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K923611 · LIT
Boston Scientific Corp
Cardiovascular · 471d
Cleared Oct 06, 1993
MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER...
K933975 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 54d
Cleared Sep 30, 1993
MEADOX SURGIMED BALLOON CATHETER
K923947 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 421d
Cleared Sep 16, 1993
MS DISPOSABLE RIGID DOPPLER PROBE
K930227 · DPW
Meadox Medicals, Div. Boston...
Radiology · 240d
Cleared Sep 03, 1993
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · FDX
Boston Scientific Corp
Gastroenterology & Urology · 221d