FDA.reportPublic FDA data

OSYPKA MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20328363004185614OSYPKA MEDICAL, INC.1Y2026-01-011252 Via Barranca LA JOLLA CA US 92037
96814493007486998OSYPKA MEDICAL GMBH1N2026-01-01Albert-Einstein-Strasse 3 BERLIN DE 12489

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260451441012CARDIOTRONIC - PACE 101 External Single-Chamber Pacemaker (with clamping terminals)+1 858 454 0600mail@cardiotronic.net
04260451441029CARDIOTRONIC - PACE 203 External Dual-Chamber Pacemaker (with clamping terminals)+1 858 454 0600mail@cardiotronic.net
04260451441043CARDIOTRONIC - ICON Non-invasive Hemodynamic Cardiometer+1 858 454 0600mail@cardiotronic.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
531351284935181K123916PSA SERIESDTE2013-04-09
531351516984292K082242ICON, MODEL C3DSB2008-10-08
531351703854442K081035AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2DSB2008-05-30
531351698193075K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATORDTE2003-10-31
531351655488608K020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENEDTE2002-06-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTE32013-04-09
DSB22008-10-08

PMN#

GUDID#