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"
601–624 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Nov 24, 1999
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K993648 · MCW
Boston Scientific Corporation...
Cardiovascular · 26d
Cleared Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · JCT
Boston Scientific Corp
General & Plastic Surgery · 114d
Cleared Nov 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · MTD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Boston Scientific Corp
Cardiovascular · 90d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 61d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 375d
Cleared Jun 28, 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL...
K990705 · DYB
Medamicus, Inc.
Cardiovascular · 116d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 84d
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · MND
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Mar 11, 1999
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
K983171 · MTD
Boston Scientific Corp
Cardiovascular · 182d
Cleared Mar 05, 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · MBI
Boston Scientific Corp
Orthopedic · 35d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Boston Scientific Corp
Cardiovascular · 232d
Cleared Nov 09, 1998
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE...
K982840 · IYO
Boston Scientific Corp
Radiology · 89d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · LJT
Boston Scientific Corp
General Hospital · 64d
Cleared Oct 16, 1998
FLEXIMA
K982508 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566 · FOZ
Boston Scientific Corp
General Hospital · 213d
Cleared Sep 03, 1998
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU)...
K981981 · GEI
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Sep 02, 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 60d
Cleared Aug 11, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K980453 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 187d
Cleared Jul 21, 1998
WALLSTENT ENDOPROSTHESIS
K982184 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jun 04, 1998
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K981413 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 23d
Cleared Apr 22, 1998
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · IYO
Boston Scientific Corp
Radiology · 48d