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"
625–648 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
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
Cleared Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER...
K973113 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 82d
Cleared Oct 09, 1997
CRE BALLOON DILATATION CATHETER
K971320 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 182d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · DSP
Boston Scientific Corp
Cardiovascular · 89d
Cleared Aug 29, 1997
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · MCW
Boston Scientific Corp
Cardiovascular · 214d
Cleared Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
K971906 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 89d
Cleared Aug 05, 1997
40 CC SUMO
K971673 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · DQO
Boston Scientific Corp
Cardiovascular · 191d
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · DQO
Boston Scientific Corp
Cardiovascular · 84d