510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Visitec Co.

Walker, MI, US

Visitec Co. appears in FDA device records in Walker, MI. FDA records list 49 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
49
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 49 510(k) clearances for Visitec Co. between 1979 and 1995. The busiest year on record is 1981, with 7. The most recent is 1995, with 4.

Clearances by year, as a table
510(k) clearance decisions for Visitec Co., by decision year
YearClearances
19793
19817
19821
19832
19845
19857
19892
19907
19912
19925
19931
19943
19954
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}LZUSubstantially Equivalent
K945114VISITEC SCLERAL PLUGLXPSubstantially Equivalent
K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEHMTSubstantially Equivalent
K945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSHQXSubstantially Equivalent
K942234VISITEC PRECISE-POINTGAPSubstantially Equivalent
K934269FIBEROPTIC ILLUMINATED INSTRUMENTSHJMSubstantially Equivalent
K940210VISITEC EYE PADEFQSubstantially Equivalent
K933872VISI-SPEAR EYE SPONGEHOZSubstantially Equivalent
K923972OPHTHALMIC FLUID DISTRIBUTION SETSFPKSubstantially Equivalent
K922530VISITEC MICROSURGICAL SUTUREGARSubstantially Equivalent
K923645VISITEC ASPIRATING SYRINGEFMFSubstantially Equivalent
K915808AQUEOUS PARACENTESIS PIPETKYGSubstantially Equivalent
K915809VISITEC CANALICULAR STENTLZUSubstantially Equivalent
K910516DISPOSAL PAD FOR SHARPSMMKSubstantially Equivalent
K904074VITREORETINAL INFUSION CANNULAHMXSubstantially Equivalent
K902857VISI-DRAPE OPHTHALMIC DRAPESHMYSubstantially Equivalent
K902750VISI-SWAB OPHTALMIC SPONGEHOZSubstantially Equivalent
K902010VISI - STICK OPHTHALMIC SUTURE RETAINER TAPEKGXSubstantially Equivalent
K900786VISI-SORB ABSORBANT STICKHOZSubstantially Equivalent
K896622VISITEC VITRECTOMY UNITHKPSubstantially Equivalent
K896705VISITEC MICRO-SPONGE SPEARSHOZSubstantially Equivalent
K896681SOFT CORNEAL LIGHT SHIELDHOYSubstantially Equivalent
K885232FLUID DRAINAGE WICKHOZSubstantially Equivalent
K884924VISI-WIPEHOFSubstantially Equivalent
K853961VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100HQESubstantially Equivalent
K853035HESSBURG LIGHT GUARDHOYSubstantially Equivalent
K852529HESSBURG GLIDE UNTRAOCULAR LENS GUIDESHQFSubstantially Equivalent
K853243VISITEC IRRIGATION CONTROL SYSTEMKYGSubstantially Equivalent
K852032OCULAR PRESSURE REDUCER (MCCANNEL)LCCSubstantially Equivalent
K853135VISITEC 2 MICRON FLUID FILTERHQESubstantially Equivalent
K843487VISITEC OPHTHALMIC FLUID DISTRIB- SETHQCSubstantially Equivalent
K844038VISITEC MAGNIFYING SPECTACLESHOISubstantially Equivalent
K843592VICO MICRO SURGICAL INSTRUMENTSHWQSubstantially Equivalent
K843197VISITEC EYE SHIELDHMPSubstantially Equivalent
K843196VISITEC EYE SPECULUMHNCSubstantially Equivalent
K843195VISITEC FLIERINGA-LEGRAND FIXATION RINGHMHSubstantially Equivalent
K831996MICRO SURGICAL HANDLEKYGSubstantially Equivalent
K831901LACIMAL INTUBATION SETSHNLSubstantially Equivalent
K820618MICROSURGERY KNIFEHNNSubstantially Equivalent
K812723PEARCE CORNEAL TREPHINEHRHSubstantially Equivalent
K811965VISITEC NEEDLE RANGE (GASTERUROLOGY)FHRSubstantially Equivalent
K811960VISITEC NEDDLE TANGE (SURGERY)Substantially Equivalent
K811966VISITEC NEEDLE RANGE (GENERAL HOSPITAL)FMISubstantially Equivalent
K811964VISITEC NEEDLE RANGE (CARDIOVASCULAR)DRCSubstantially Equivalent
K811961VISITEC NEEDLE RANGE (ORTHOPAEDIC)Substantially Equivalent
K811963VISITEC NEEDLE RANGE (ANESTHESIOLOGY)BSPSubstantially Equivalent
K782169NEEDLES, CANNULAS, CYSTOTOMESHMXSubstantially Equivalent
K790244CYSTOTOMESHNYSubstantially Equivalent
K790243CANNULASHMXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain