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"
673–696 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jan 06, 1997
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
K964284 · DTK
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 12, 1996
INTRAVASCULAR INFUSION DEVICE
K963988 · KRA
Boston Scientific Corp
Cardiovascular · 69d
Cleared Dec 12, 1996
COURIER BALLOON DILATATION CATHETER
K963691 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Dec 04, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 50d
Cleared Nov 25, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Nov 22, 1996
RETRIEVAL SNARE
K963750 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 65d
Cleared Nov 19, 1996
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · DYG
Boston Scientific Scimed, Inc.
Cardiovascular · 181d
Cleared Nov 15, 1996
SURGICAL FABRICS
K963226 · FTL
Boston Scientific Corp
General & Plastic Surgery · 88d
Cleared Nov 14, 1996
ULTRAFLEX
K963241 · JCT
Boston Scientific Corp
General & Plastic Surgery · 87d
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930...
K963187 · DSP
Boston Scientific Corp
Cardiovascular · 82d
Cleared Oct 22, 1996
ELECTRODE RECORDING CATHETER
K954651 · DRF
Boston Scientific Corp
Cardiovascular · 378d
Cleared Oct 17, 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
K961499 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 182d
Cleared Sep 20, 1996
TBAN
K963252 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 32d
Cleared Sep 10, 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 84d
Cleared Sep 04, 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 76d
Cleared Jul 31, 1996
BALLON DILATATION CATHETER
K961438 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jul 15, 1996
NEEDLE CATHETER
K961846 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jul 10, 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 82d
Cleared Jul 10, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 97d
Cleared Jul 10, 1996
WALLSTENT ENTERAL ENDOPROTHESIS
K954290 · MQR
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 300d
Cleared Jun 21, 1996
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · GEH
Boston Scientific Corp
General & Plastic Surgery · 85d
Cleared May 30, 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR...
K955460 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 15, 1996
INJECTION GOLD PROBE
K961349 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 37d
Cleared May 10, 1996
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY...
K961262 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 38d