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Boston Scientific Corp

432 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21
EXPEL APD DRAINAGE CATHETER SYSTEM (K141335)Boston Scientific Corp2014-10-17
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM (K141344)Boston Scientific Corp2014-10-17
PTA BALLOON DILATATION CATHETER (K141150)Boston Scientific Corp2014-09-25
Direxion Torqueable Microcatheter (K142259)Boston Scientific Corp2014-09-10
EQUALIZER OCCLUSION BALLOON CATHETER (K140273)Boston Scientific Corp2014-07-22
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV (K140726)Boston Scientific Corp2014-07-21
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K141185)Boston Scientific Corp2014-06-06
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE (K140495)Boston Scientific Corp2014-04-17
ENCORE 26 ADVANTAGE KIT (K140745)Boston Scientific Corp2014-04-17
TRUEPATH CTO DEVICE (K140288)Boston Scientific Corp2014-04-16
INSERTION TOOL (K140673)Boston Scientific Corp2014-04-16
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER (K132810)Boston Scientific Corp2014-02-28
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS (K133566)Boston Scientific Corp2013-12-20
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K133208)Boston Scientific Corp2013-11-14
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES (K131700)Boston Scientific Corp2013-11-04
OFFROAD RE-ENTRY CATHETER SYSTEM (K131914)Boston Scientific Corp2013-10-31
OCCLUSION BALLOON CATHETER (K132990)Boston Scientific Corp2013-10-22
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS (K132947)Boston Scientific Corp2013-10-18
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER (K132430)Boston Scientific Corp2013-10-17
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM (K132578)Boston Scientific Corp2013-09-13
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER (K130484)Boston Scientific Corp2013-08-09
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT (K130391)Boston Scientific Corp2013-07-10
GATEWAY ADVANAGE Y-ADAPTER (K130909)Boston Scientific Corp2013-05-16
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER (K123621)Boston Scientific Corp2013-04-15
ILAB ULTRASOUND IMAGING SYSTEM (K130243)Boston Scientific Corp2013-03-01
MDU5 PLUS STERILE BAG (K123424)Boston Scientific Corp2013-02-20
ILAB ULTRASOUND IMAGING SYSTEM (K123535)Boston Scientific Corp2013-01-15
UPSYLON Y MESH (K122794)Boston Scientific Corp2012-12-18
NAVIGATOR HD URETERAL ACCESS SHEATH SET (K122649)Boston Scientific Corp2012-12-12
ENCORE 26 ADVANTAGE KIT (K123214)Boston Scientific Corp2012-11-13
CRE FIXED WIRE BALLON DILATION CATHETER (K122924)Boston Scientific Corp2012-10-24
BLUE SUI SLING (K121754)Boston Scientific Corp2012-10-10
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER (K121614)Boston Scientific Corp2012-09-18
IMAGER II ANGIOGRAPHIC CATHETER (K121694)Boston Scientific Corp2012-09-14
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS (K121774)Boston Scientific Corp2012-09-13
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K121196)Boston Scientific Corp2012-08-31
RUBICON 18 SUPPORT CATHETER (K122394)Boston Scientific Corp2012-08-30
TRUETOME (K122203)Boston Scientific Corp2012-08-17
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) (K121667)Boston Scientific Corp2012-08-13
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (K121048)Boston Scientific Corp2012-08-03
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495)Boston Scientific Corp2012-05-21
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (K121186)Boston Scientific Corp2012-05-16
ENCORE 26 ADVANTAGE KIT (K120694)Boston Scientific Corp2012-04-03
IMAGER II ANGIOGRAPHIC CATHETERS (K120893)Boston Scientific Corp2012-03-29
LITE PELVIC FLOOR REPAIR KITS (K103426)Boston Scientific Corp2011-09-14
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K112103)Boston Scientific Corp2011-08-12
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER (K111043)Boston Scientific Corp2011-08-04
FATHOM (TM) 14 STEERABLE GUIDEWIRE (K111498)Boston Scientific Corp2011-06-30
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F (K111252)Boston Scientific Corp2011-06-02
ACUITY WHISPER VIEW GUIDE WIRES (K110479)Boston Scientific Corp2011-04-08
FLEXIVA TRACTIP (K110685)Boston Scientific Corp2011-03-29
ACCUTRAC (K110686)Boston Scientific Corp2011-03-28
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K110295)Boston Scientific Corp2011-03-03
GDC 360 DETEACHABLE COIL (K103355)Boston Scientific Corp2011-02-16
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL (K102714)Boston Scientific Corp2011-02-11
EXPECT ENDOSCOPIC ASPIRATION NEEDLE (K110030)Boston Scientific Corp2011-01-12
INZONE DETACHMENT SYSTEM (K103008)Boston Scientific Corp2010-12-10
TARGET DETACHABLE COIL (K102672)Boston Scientific Corp2010-10-15
RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 (K101657)Boston Scientific Corp2010-10-05
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 (K102082)Boston Scientific Corp2010-08-23
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM (K101314)Boston Scientific Corp2010-07-23
ADVANIX DOUBLE PIGTAIL BILIARY STENT (K101786)Boston Scientific Corp2010-07-23
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX (K100892)Boston Scientific Corp2010-04-12
MODIFIED STRAIGHT FIRE LASER FIBER (K100078)Boston Scientific Corp2010-02-12
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM (K093142)Boston Scientific Corp2010-02-04
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO (K093720)Boston Scientific Corp2009-12-23
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX (K093636)Boston Scientific Corp2009-12-23
ACCUMAX (K093691)Boston Scientific Corp2009-12-11
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 (K092666)Boston Scientific Corp2009-09-30
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE (K090554)Boston Scientific Corp2009-07-02
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340)Boston Scientific Corp2009-06-09
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM (K083374)Boston Scientific Corp2009-04-22
SPYSCOPE ACCESS AND DELIVERY CATHETER (K090170)Boston Scientific Corp2009-02-04
BLAZER DX-20 DIAGNOSTIC CATHETER (K081576)Boston Scientific Corp2009-02-03
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT (K081739)Boston Scientific Corp2008-12-03
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 (K081733)Boston Scientific Corp2008-10-27
STRAIGHT FIRE HOLMIUM LASER FIBER (K082928)Boston Scientific Corp2008-10-16
BOSTON SCIENTIFIC SURGICAL MESH (K081275)Boston Scientific Corp2008-08-27
PINNACLE PELVIC FLOOR REPAIR KIT II (K081048)Boston Scientific Corp2008-08-22
KINETIX GUIDEWIRE, PLUS GUIDEWIRE (K081021)Boston Scientific Corp2008-08-08
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS (K080982)Boston Scientific Corp2008-07-14
ATLANTIS 018 PERIPHERAL IMAGING CATHETER (K073623)Boston Scientific Corp2008-03-13
ATLANTIS PVIMAGING CATHETER, MODEL H749364560 (K080272)Boston Scientific Corp2008-03-11
CONVOY ADVANCED DELIVERY SHEATH (K072719)Boston Scientific Corp2008-03-07
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM (K073266)Boston Scientific Corp2008-02-27
PINNACLE PELVIC FLOOR REPAIR KITS (K071957)Boston Scientific Corp2007-11-08
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 (K072517)Boston Scientific Corp2007-09-26
BLUE MAX BALLOON DILATATION CATHETER (K071309)Boston Scientific Corp2007-07-13
MODIFICATION TO:CONTOUR SE MICROSPHERES (K071634)Boston Scientific Corp2007-07-12
SPYCATCH STONE RETRIEVAL BASKET (K071066)Boston Scientific Corp2007-06-29
POLARCATH PERIPHERAL DILATATION SYSTEM (K071042)Boston Scientific Corp2007-06-13
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 (K063493)Boston Scientific Corp2006-12-21
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Every clearance here is in the API, with alerts when new ones post.