Home / Companies / Boston Scientific Scimed, Inc.

Boston Scientific Scimed, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

No warning letters matched by name

Inspections 0 0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 35 Latest Jul 23, 2004

Boston Scientific Scimed, Inc. has 0 FDA recalls, 0 inspections, 35 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston Scientific Scimed, Inc." is on file.

What these totals cover: FDA records filed under the name "Boston Scientific Scimed, Inc." and its spelling variant "Boston Scientific Scimed". Records filed under related names are not included; see Related names.

Latest recall: Z-0311-2027 · Sep 30, 2026 · filed under Boston Scientific Neuromodulation Corporation
Latest 510(k): Jul 23, 2004

Newer recall under related name Boston Scientific Neuromodulation Corporation: Sep 30, 2026, Z-0311-2027.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	35	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	0	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Boston Scientific Scimed, Inc. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Boston Scientific Neuromodulation Corporation Combines 2 spellings Boston Scientific Neuromodulation Corporation: 25 recalls, 1 510(k), 8 inspections Boston Scientific Neuromodulation: 9 510(k)s	Same company group	25	10	8	0	Sep 30, 2026 (Z-0311-2027)
Boston Scientific Corporation Combines 3 spellings Boston Scientific Corporation: 642 recalls, 239 510(k)s, 84 inspections, 1 compliance action Boston Scientific: 19 recalls, 494 510(k)s, 15 inspections Boston Scientific Limited: 1 510(k), 6 inspections	Same company group	661	734	105	1	Sep 10, 2026 (Z-0143-2027)
Baylis Medical Company Combines 3 spellings Baylis Medical Company: 3 recalls, 24 510(k)s Baylis Medical: 1 510(k) Baylis Medical Co: 28 510(k)s, 1 inspection	Same company group	3	53	1	0	Oct 7, 2019 (Z-2070-2020)
Cardiac Science Corporation Combines 2 spellings Cardiac Science Corporation: 2 recalls, 10 510(k)s, 3 inspections Cardiac Science: 11 510(k)s	Same company group	2	21	3	0	Jun 4, 2019 (Z-1938-2019)
Endochoice	Same company group	1	27	0	0	Dec 18, 2015 (Z-0694-2016)
American Medical Systems	Same company group	6	82	0	0	Oct 15, 2014 (Z-0806-2015)
Guidant Combines 2 spellings Guidant: 71 510(k)s Guidant Corporation: 15 510(k)s	Same company group	0	86	0	0	—
Boston Scientific De Costa Rica	Same company group	0	0	7	0	—
Btg International	Same company group	0	6	1	0	—
Endochoice Wcdc	Same company group	0	0	2	0	—
Boston Scientific Cardiac Diagnostic Technologies	Same company group	0	1	0	0	—
Endochoice Scope Services	Same company group	0	0	1	0	—

Recent 510(k) clearances

35 510(k) clearances from Jun 2, 1994 to Jul 23, 2004. Showing the 20 most recent. View all 35 510(k) clearances

K-Number	Device	Date
K041727	MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456	Jul 23, 2004
K030617	PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE	May 21, 2003
K024048	MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM	Jan 6, 2003
K021735	BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER	Aug 8, 2002
K021901	WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	Jul 9, 2002
K012822	MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX	Oct 24, 2001
K012216	NIROYAL BILIARY PREMOUNTED STENT SYSTEM	Aug 17, 2001
K000743	BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020	Sep 6, 2000
K000001	WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM	Jun 5, 2000
K000956	MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS	Apr 21, 2000
K993232	WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM	Dec 30, 1999
K992123	SCIMED IMPULSE ANGIOGRAPHIC CATHETERS	Aug 23, 1999
K982005	WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS	Sep 2, 1998
K982077	SELECTOR DIAGNOSTIC CATHETER	Aug 11, 1998
K980453	SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS	Aug 11, 1998
K982184	WALLSTENT ENDOPROSTHESIS	Jul 21, 1998
K981413	SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS	May 13, 1998
K980113	WALLSTENT ENTERAL ENDOPROSTHESIS	Apr 3, 1998
K980163	WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH…	Mar 13, 1998
K972512	SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL	Feb 12, 1998

Boston Scientific Scimed, Inc. and the FDA: common questions

Has Boston Scientific Scimed, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Boston Scientific Scimed, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Boston Scientific Scimed, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Boston Scientific Scimed, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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