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"
529–552 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · DQY
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jun 06, 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · HCG
Boston Scientific, Target
Neurology · 28d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · MAL
Boston Scientific Corp
Cardiovascular · 2d
Cleared Apr 16, 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared Apr 03, 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · OTN
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Boston Scientific Corp
Toxicology · 88d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · MMX
Boston Scientific, Target
Cardiovascular · 88d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · DQX
Boston Scientific Corp
Cardiovascular · 14d
Cleared Jan 31, 2002
MATRIX DETACHABLE COILS
K012985 · HCG
Boston Scientific, Target
Neurology · 147d
Cleared Jan 29, 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 26d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028 · DQY
Boston Scientific
Cardiovascular · 18d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · DQY
Boston Scientific Corp
Cardiovascular · 186d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866 · DBY
Boston Scientific
Immunology · 23d
Cleared Dec 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · DQY
Boston Scientific, Target
Cardiovascular · 22d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 162d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 91d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 58d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
K012883 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
K012948 · MSD
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 29d