FDA.reportPublic FDA data

Bone file/rasp, reciprocating, single-use

Definition
A surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use device.
GUDID devices
146
Last updated
2026-11-06 11:29:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00842078102244Omni MTPEXTREMITY MEDICAL, LLC113-001142026-10-28
00842078102251Omni MTPEXTREMITY MEDICAL, LLC113-001162026-10-28
00842078102268Omni MTPEXTREMITY MEDICAL, LLC113-001182026-10-28
00842078102299Omni MTPEXTREMITY MEDICAL, LLC113-002142026-10-28
00842078102305Omni MTPEXTREMITY MEDICAL, LLC113-002162026-10-28
00842078102312Omni MTPEXTREMITY MEDICAL, LLC113-002182026-10-28
00842078107973XMCPEXTREMITY MEDICAL, LLC120-020122026-10-28
00842078107980XMCPEXTREMITY MEDICAL, LLC120-020162026-10-28
00842078108017XMCPEXTREMITY MEDICAL, LLC120-040122026-10-28
00842078108024XMCPEXTREMITY MEDICAL, LLC120-040162026-10-28
00842078108291APEXEXTREMITY MEDICAL, LLC121-001082026-10-28
00842078108307APEXEXTREMITY MEDICAL, LLC121-001102026-10-28
00842078108338APEXEXTREMITY MEDICAL, LLC121-002082026-10-28
00842078108345APEXEXTREMITY MEDICAL, LLC121-002102026-10-28
00842078116104Omni PlatingEXTREMITY MEDICAL, LLC144-000302026-10-28
00842078121009KinematX TotalEXTREMITY MEDICAL, LLC137-000062026-10-28
00841731153135ARTEMIS TAKEDOWNVILEX LLCATIB-0615-032026-07-22
00841731153142ARTEMIS TAKEDOWNVILEX LLCATIB-0615-042026-07-22
00841731153159ARTEMIS TAKEDOWNVILEX LLCATIB-0625-032026-07-22
00841731153166ARTEMIS TAKEDOWNVILEX LLCATIB-0625-042026-07-22
00841731153173ARTEMIS TAKEDOWNVILEX LLCATIB-0915-032026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCATIB-0915-042026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCATIB-0925-032026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCATIB-0925-042026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCATIB-1225-032026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCATIB-1225-042026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCATIB-1235-032026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCATIB-1235-042026-07-22
00842078125724CarilaginatorEXTREMITY MEDICAL, LLC168-050102026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLC168-050202026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLC170-021412026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLC170-021402026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLC170-012512026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLC170-012502026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLC170-000112026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLC168-05010-S2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLC168-05020-S2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLC170-00011-S2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLC170-01250-S2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLC170-01251-S2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLC170-02140-S2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLC170-02141-S2026-06-09
00847399001054MicroAire® Microaire Surgical Instruments LLC1400-0112022-09-17
00847399001061MicroAire® Microaire Surgical Instruments LLC1400-0132022-09-17
00847399014795MicroAire® Microaire Surgical Instruments LLCZR-0802022-09-17
00847399014801MicroAire® Microaire Surgical Instruments LLCZR-0812022-09-17
00847399014818MicroAire® Microaire Surgical Instruments LLCZR-0822022-09-17
00847399014825MicroAire® Microaire Surgical Instruments LLCZR-0832022-09-17
00847399014832MicroAire® Microaire Surgical Instruments LLCZR-083NS2022-09-17
00847399014849MicroAire® Microaire Surgical Instruments LLCZR-0842022-09-17
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.KM81RH2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.KM80RH2025-01-29
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.5053083R2025-02-14
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.510037114RH2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.KM800RH2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.KM802RH2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.ZR080RH2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.KM82RH2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.SR082RH2025-01-29
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.5053082R2025-02-14
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.5053080RH2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.510037125RH2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.KM5100374RH2025-01-29
10888277386938MEDLINEMEDLINE INDUSTRIES, INC.KM5100373RH2025-01-29
10888277388383MEDLINEMEDLINE INDUSTRIES, INC.KM5100372RH2025-01-29
10888277389434MEDLINEMEDLINE INDUSTRIES, INC.03000360RH2025-01-29
10888277403710MEDLINEMEDLINE INDUSTRIES, INC.1675125RH2025-01-29
10888277407206MEDLINEMEDLINE INDUSTRIES, INC.1675113RH2025-01-29
14053613215128Saw BladeGebr. Brasseler GmbH & Co. KG5080-0072022-12-08
14053613218150Saw Blade RaspGebr. Brasseler GmbH & Co. KGAR-300-056S2019-03-21
14053613218167Saw Blade RaspGebr. Brasseler GmbH & Co. KGAR-300-053S2019-03-21
14053613218174Saw Blade RaspGebr. Brasseler GmbH & Co. KGAR-300-054S2019-03-21
14053613293195Saw Blade Rasp, Small Tear replaces Stryker®Gebr. Brasseler GmbH & Co. KGMRSP55022025-09-30
14053613293225Saw Blade Rasp, Small Tear Cross Cut replaces Stryker®Gebr. Brasseler GmbH & Co. KGMRSP55012025-09-30
14053613293232Saw Blade Rasp, Large Tear replaces Stryker®Gebr. Brasseler GmbH & Co. KGMRSP70022025-09-30
14053613293249Saw Blade Rasp, Large Tear Cross Cut replaces Stryker®Gebr. Brasseler GmbH & Co. KGMRSP70012025-09-10
14053613294512Small Tear Cross Cut replaces Stryker®Gebr. Brasseler GmbH & Co. KGTM5511RD2025-07-24
14053613294529Small Tear replaces Stryker®Gebr. Brasseler GmbH & Co. KGTM5511RS2025-07-28
24053613294519Small Tear Cross Cut replaces Stryker®Gebr. Brasseler GmbH & Co. KGTM5511RD2025-07-24
24053613294526Small Tear replaces Stryker®Gebr. Brasseler GmbH & Co. KGTM5511RS2025-07-28