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"
793–816 of 881
Search insights Median review: 80d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Sep 03, 1993
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · DRF
Boston Scientific Corp
Cardiovascular · 380d
Cleared Aug 30, 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · DSP
Boston Scientific Corp
Cardiovascular · 276d
Cleared Aug 20, 1993
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · GCA
Boston Scientific Corp
Gastroenterology & Urology · 140d
Cleared Aug 10, 1993
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
K932228 · GBZ
Boston Scientific Corp
General & Plastic Surgery · 95d
Cleared Jul 13, 1993
MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
K931379 · HCF
Boston Scientific Corp
General & Plastic Surgery · 117d
Cleared Jun 25, 1993
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared May 27, 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 70d
Cleared May 20, 1993
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)
K921706 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 405d
Cleared Apr 29, 1993
AMPLATZ GUIDEWIRES
K930622 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 80d
Cleared Apr 27, 1993
SPHINCTEROTOME
K930022 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 112d
Cleared Apr 08, 1993
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · GBX
Boston Scientific Corp
General & Plastic Surgery · 176d
Cleared Feb 08, 1993
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Dec 23, 1992
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Dec 21, 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 200d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · MAV
Boston Scientific Corp
Cardiovascular · 190d
Cleared Dec 03, 1992
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · LIT
Boston Scientific Corp
Cardiovascular · 262d
Cleared Nov 23, 1992
TRELEX MESH
K924749 · FTL
Meadox Medicals, Div. Boston...
General & Plastic Surgery · 62d
Cleared Nov 18, 1992
BALLOON DILATATION CATHETER
K922610 · LIT
Boston Scientific Corp
Cardiovascular · 169d
Cleared Nov 10, 1992
SHORT TEGWIRE -- MODIFIED
K924276 · LIT
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 09, 1992
SONICATH(TM) 3.5 F, 20 MHZ
K913890 · ITX
Boston Scientific Corp
Radiology · 438d
Cleared Nov 02, 1992
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER
K924047 · LIT
Boston Scientific Corp
Cardiovascular · 83d
Cleared Sep 01, 1992
MEADOX SURGIMED BIOPSY GUN III
K922879 · KNW
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 78d
Cleared Aug 14, 1992
DOWD(TM) II
K922349 · KOE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Aug 12, 1992
CATHETER INTRODUCER
K920528 · DYB
Boston Scientific Corp
Cardiovascular · 189d