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SYNERGETICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19324021000119053SYNERGETICS, INC.1Y2026-01-013845 Corporate Centre Dr O Fallon MO US 63368
25215672521567Synergetics USA (a Bausch and Lomb Company)1N2020-04-25500 Coventry Lane 2nd Floor Croydon PA US 19021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
457171296176715K993039VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)MRH2000-01-07
457171441928156K982212VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010GEI1998-12-02
77521479597597K955346VFS - 300 BIPOLAR ELECTROSURGERY SYSTEMGEI1995-12-08
457171487060838K955346VFS - 300 BIPOLAR ELECTROSURGERY SYSTEMGEI1995-12-08
457171076830561K954308GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBEHQB1995-12-22
457171045610561K954307GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBEHQB1995-12-22
457171666097928K954306GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBEHQB1995-12-22
457171815818218K952586GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATORMPA1995-09-01
457171918758908K952585GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATORMPA1996-01-05
457171206052192K952584GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICKMPA1995-09-01
457171498542732K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORHQR1996-01-05
457171257992413K951985PRECISION BIPOLAR COAGULATORGEI1995-05-23
457171921544209K950287UNIVIT PROBEHKP1995-04-10
457171013626954K932668OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVERHQE1994-02-23
457171168842862K890648MALIS BIPOLAR CORD/IRRIGATION TUBING SETGEI1989-03-03
457171194911436K121675VERSAVITHQE2012-06-21
457171842556265K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEI2012-07-10
457171043048539K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBEHQB2012-04-23
457171504745421K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEI2011-12-07
457171865280621K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SETFRN2009-10-30
77521879853919K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000GXD2007-12-20
77521476687960K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMGEI2005-03-09
77521827175908K033499MALIS IRRIGATION MODULE 1000GEI2003-11-28
77521854559360K032601STRYKER INTERVENTIONAL PAIN RF GENERATORGXD2004-04-01
457171600478362K032598SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCEMPA2003-11-24
457171888571198K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTELFL2002-08-23
457171281864318K010309SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATORLFL2001-04-18
457171026487838
457171123312964
457171152802408
457171223867462
457171534006619
457171459385787
457171538794938
457171634187620
457171696182130
457171752059615
457171794556318
457171801818688
457171986808509
457172032230820
457172051428027

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI92012-07-10
HQB52012-04-23
MPA42003-11-24
HQE22012-06-21
GXD22007-12-20
LFL22002-08-23
FRN12009-10-30
MRH12000-01-07
HQR11996-01-05
HKP11995-04-10

PMN#

GUDID#

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