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

New Berlin, WI, US

ESCALON MEDICAL CORP appears in FDA device records in New Berlin, WI. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Escalon Medical Corp between 2000 and 2009. The busiest year on record is 2000, with 1. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Escalon Medical Corp, by decision year
YearClearances
20001
20081
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K093613VASCUVIEW TAP ULTRASOUND SYSTEMIYNSubstantially Equivalent
K080049VASCUVIEW ULTRASOUND SYSTEMIYOSubstantially Equivalent
K002920MEGAVISION CPX, MEGAVISION FA, MODEL I AND IIHKISubstantially Equivalent

Registered establishments

FDA registered establishments for Escalon Medical Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21834772183477ESCALON MEDICAL CORP2440 SOUTH 179TH ST., NEW BERLIN, WI 53146 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0132-2011PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access DevicesThe packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access Vascular Access Device, Model 78060 Extended 18 Gauge PD Access Vascular Access Device, Model 75010 18 Gauge SmartNeedle Vascular Access Devices with Expiration DaTerminated

Verification record

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