ClearanceBrief
Company

3M Company / Medical Division

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
KGXTape And Bandage, Adhesive8
ELZCrown, Preformed2
JOJIndicator, Physical/Chemical Sterilization Process2
DRXElectrode, Electrocardiograph1
FRCIndicator, Biological Sterilization Process1
FRLFiber, Medical, Absorbent1
FRODressing, Wound, Drug1
JOSElectrode, Electrosurgical1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 26, 20103M Company / Medical Division
3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150
Terminated
ELZNone listed
Sep 7, 20103M Company / Medical Division
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
Terminated
DRXK970796
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.
Terminated
KGXNone listed
Apr 20, 20103M Company / Medical Division
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
Terminated
KGXNone listed
Aug 8, 20083M Company / Medical Division
3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical i
Terminated
JOJNone listed
Jan 24, 20083M Company / Medical Division
3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.
Terminated
ELZNone listed
Oct 11, 20063M Company / Medical Division
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Terminated
JOJK013228
Jul 13, 20063M Company / Medical Division
3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774.
Terminated
FRLNone listed
Nov 30, 20043M Company / Medical Division
3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with
Terminated
FRONone listed
Oct 22, 20043M Company / Medical Division
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Terminated
JOSK833364
Jul 20, 20043M Company / Medical Division
3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
Terminated
FRCNone listed
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