FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

892 results for "Boston Scientific"
625–648 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Apr 22, 1998
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Apr 03, 1998
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · MUM
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 80d
Cleared Mar 20, 1998
CRE(TM) BALLOON DILATATION CATHETER
K974788 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Mar 13, 1998
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL...
K980163 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 56d
Cleared Mar 13, 1998
COAXIAL DILATOR SET
K974640 · DRE
Boston Scientific Corp
Cardiovascular · 88d
Cleared Feb 12, 1998
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
K972512 · LIT
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared Feb 10, 1998
40 CC GRANDE
K974247 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Feb 09, 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 68d
Cleared Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818 · DWZ
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
K973008 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 124d
Cleared Dec 11, 1997
COURIER ST BALLOON DILATATION CATHETER
K972744 · LIT
Boston Scientific Corp
Cardiovascular · 141d
Cleared Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · DQX
Boston Scientific /International...
Cardiovascular · 218d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · KRA
Boston Scientific Corp
Cardiovascular · 56d
Cleared Nov 19, 1997
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · LIT
Boston Scientific Corp
Cardiovascular · 147d