Boston Scientific Corp
Boston Scientific Corp holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2024, with 7 FDA device recalls on record.
Clearances by Boston Scientific Corp — page 2
101–200 of 432- K063313 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
- K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- K063312 — MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
- K062202 — OCCLUSION BALLOON
- K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR
- K061877 — WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
- K061231 — WELLFLEX BILIARY RX STENT SYSTEM
- K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
- K060947 — SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
- K051984 — FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
- K060175 — ISIGHT IMAGING CATHETER, MODEL 38986
- K060419 — CONCERTO BIPOLAR NEEDLE ELECTRODE
- K052964 — EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
- K051880 — RIO ASPIRATION CATHETER
- K053116 — STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
- K053118 — STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
- K053128 — SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
- K052280 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
- K052783 — MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
- K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
- K050863 — IMAGER II ANGIOGRAPHIC CATHETER
- K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
- K051679 — ILAB ULTRASOUND IMAGING SYSTEM
- K051361 — EASY CORE DETACHABLE BIOPSY SYSTEM
- K051504 — SPYSCOPE ACCESS AND DELIVERY CATHETER
- K051179 — EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
- K050599 — TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
- K050389 — ULTRA-SOFT SV BALLOON DILATATION CATHETER
- K050684 — ATLANTIS PV
- K050700 — MATRIX STRETCH RESISTANT (SR) COILS
- K050577 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
- K050361 — MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
- K050232 — RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
- K050403 — SPYGLASS DIRECT VISULATION PROBE
- K050120 — EASY CORE BIOPSY SYSTEM II
- K041818 — SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
- K042882 — ENTERYX INJECTION CATHETER
- K042539 — GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
- K042568 — EXCELSIOR 1018 AND SL-10 MICROCATHETERS
- K042065 — WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
- K041827 — DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
- K041716 — PTFE FELTS AND PLEDGETS
- K041606 — EXTRACTOR RX RETRIEVAL BALLOON
- K040155 — PERIPHERAL CUTTING BALLOON
- K040736 — VAXCEL PLUS CHRONIC DIALYSIS CATHETER
- K040893 — EASY CORE BIOPSY SYSTEM
- K040867 — PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
- K040776 — ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
- K040785 — CONCERTO BIPOLAR NEEDLE ELECTRODE
- K040148 — RESOLUTION HEMOSTASIS CLIPPING DEVICE
- K040342 — INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
- K034068 — CONTOUR SE MICROSPHERES
- K040492 — VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
- K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
- K040219 — COBRA SURGICAL PROBE
- K040104 — COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0
- K040140 — IQ GUIDE WIRE
- K034061 — MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
- K040018 — EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
- K033742 — BOSTON SCIENTIFIC V-18 CONTROL WIRE
- K033441 — BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
- K032930 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K032712 — VAXCEL PLUS CHRONIC DIALYSIS CATHETER
- K032025 — SENTINOL NITINOL BILLARY STENT SYSTEM
- K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
- K032707 — CONTOUR SE MICROSPHERES (SYRINGE)
- K032542 — MODIFICATION TO CONTOUR SE MICROSPHERES
- K032600 — VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
- K032360 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
- K032207 — COBRA COOLED SURGICAL PROBE, MODEL M004159670
- K032375 — VAXCEL PORT, MODELS 45-336 AND 45-338
- K032050 — PERIVAC KIT
- K032183 — IQ HYDROPHILIC GUIDE WIRE
- K031844 — VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
- K030769 — ULTRAFLEX PRECISION COLONIC STENT
- K032008 — VAXCEL WITH PASV PORT, MODEL 45-213
- K031538 — ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
- K030956 — NAVIGATOR URETERAL ACCESS SHEATH SET
- K030855 — MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
- K030645 — BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
- K030107 — 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
- K030503 — MODIFICATION TO CONTOUR POLARIS URETERAL STENT
- K030083 — VAXCEL WITH PASV PORT
- K023681 — RENEGADE STC 18 MICROCATHETER
- K023337 — CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
- K022059 — MICROVASIVE PULMONARY GUIDEWIRE
- K021630 — BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
- K023291 — COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
- K022135 — URETERAL ACCESS SHEATH SET (UASS)
- K022648 — ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
- K022621 — BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
- K022427 — CONTOUR SE MICROSPHERES
- K013784 — URETERAL STENT
- K020120 — ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
- K013873 — COBRA CARDIAC ELECTROSURGICAL SYSTEM
- K014297 — ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P
- K021721 — EQUALIZER BALLOON CATHETER
- K021232 — CONSTELLATION CATHETERS, MODEL 8031M
- K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- K021046 — COBRA COOLED SURGICAL PROBE, MODEL 1596X
Data sourced from openFDA. This site is unofficial and independent of the FDA.