FDA.reportPublic FDA data

Tympanotomy knife, single-use

Definition
A sterile, hand-held manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a single-use device.
GUDID devices
28
Last updated
2021-01-15 09:59:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190660197940Ambler SurgicalAMBLER SURGICAL CORP.Tympanoplasty blade2021-01-07
00190660197711Ambler SurgicalAMBLER SURGICAL CORP.Needle blade2021-01-04
00190660197728Ambler SurgicalAMBLER SURGICAL CORP.Needle blade2021-01-04
00190660197889Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance blade2021-01-04
00190660197896Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance blade2021-01-04
00190660197902Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy spear blade2021-01-04
00190660197919Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance blade2021-01-04
00190660197926Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy spear knife2021-01-04
00190660197933Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance knife2021-01-04
00190660197957Ambler SurgicalAMBLER SURGICAL CORP.Tympanoplasty blade2021-01-04
00190660197964Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy sickle blade2021-01-04
00190660198121Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance knife2021-01-04
00190660198190Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance knife2021-01-04
00190660198206Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance knife2021-01-04
00190660198213Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy spear micro-point blade2021-01-04
00190660198251Ambler SurgicalAMBLER SURGICAL CORP.Tapered straight edge blade2021-01-04
00190660198268Ambler SurgicalAMBLER SURGICAL CORP.Tapered straight edge blade2021-01-04
00190660198275Ambler SurgicalAMBLER SURGICAL CORP.Tapered straight edge blade2021-01-04
00190660198282Ambler SurgicalAMBLER SURGICAL CORP.Tapered spear blade2021-01-04
00190660198299Ambler SurgicalAMBLER SURGICAL CORP.Tapered spear blade2021-01-04
00190660200374Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy lance knife2021-01-04
00190660200381Ambler SurgicalAMBLER SURGICAL CORP.Myringotomy sickle knife2021-01-04
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANY38-14002020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANY38-14022020-09-01
10381780074830Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATION14110002018-04-16
10381780074847Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATION14110502018-04-16
10381780075035Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATION14582752018-04-16
10381780075042Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATION14582762018-04-16