FDA.reportPublic FDA data

PEDIA

Matched from indexed company URL: PEDIA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30147296873014729687PEDIA1N2026-01-012804 Albany Court Fairfax VA US 22031
30208573813020857381PEDIAMETRIX INC1N2026-01-01155 Gibbs St. Suite 537 Rockville MD US 20850
30264059443026405944PEDIATRIC MEDICAL DEVICE MARKETING AND DISTRIBUTION LLC1Y2026-01-01712 Moraga Road Lafayette CA US 94549
30436688073043668807PEDIATAPE1N2026-01-01610 N MAIN ST STE C200 Blacksburg VA US 24060
10001224971000122497PEDIA PALS1Y2020-04-25230 Grider St Buffalo NY US 14215
30099708873009970887PEDIAVASCULAR INC1Y2020-04-257181 Chagrin Rd Ste 250 Chagrin Falls OH US 44023
30107293433010729343PEDIATRIC PHARMACEUTICALS INC.1N2020-04-25120 Wood Ave S Ste 601 Iselin NJ US 08830
30121039743012103974PediaLift LLC.1N2020-04-25181 Illinois Ave S. Mansfield OH US 44905

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
00860003582718PEDIA - P001Y703-966-9578diane@pediallc.com
00860003582725PEDIA - P001P703-966-9578diane@pediallc.com
00860003582749PEDIA - P001B703-966-9578diane@pediallc.com
00860009522206SoftSpot - SoftSpot is a software medical device that uses images of an infant's head to calculate cranial measurements, including Cranial Index (CI) and Cephalic Vault Asymmetry Index (CVAI). The SoftSpot platform allows users to capture and upload images for analysis and generation of measurement reports. The associated kit includes caps and accessories to support image capture quality. SoftSpot is intended for cranial measurement of infants from 1 month to 2 years of age in conjunction with other clinical methods.2406700171reza.seifabadi@pediametrix.com
B751PDLFT0PediaLift - PediaLift Crib Infant Access Device4195288180claytons@pedialift.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1494641011383358K982559GUIDEWIREDQX1999-02-01
1264661419066707K951041BLOOD PRESSURE CUFF 3DXQ1995-10-31
1264661156047661K951040BLOOD PRESSURE CUFF 2DXQ1995-10-31
2984642038827171K212045SoftSpotQQO2021-09-28
2345311385040516K181424PeDIABTC2018-09-25
1659751838317040K131617COLONGLIDE(R) LUBRICANTKMJ2013-10-03
1494641036604521K121504SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETSDYB2012-09-27
1494641869713633K113819MONGOOSE ANGIOGRAPHIC CATHETERDQO2012-07-11
1264661116514648
1264661146408437
1264661251027306
1264661279444793
1264661307334230
1264661461494419
1876631665445025
1264661674138020
1264661691555512
3485941041121132
3485941927313318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXQ21995-10-31
QQO12021-09-28
BTC12018-09-25
KMJ12013-10-03
DYB12012-09-27
DQO12012-07-11
DQX11999-02-01

NDC#

PMN#

PeDIA

2018-09-25

PeDIA, LLC

Applications#

GUDID#

SoftSpot - SoftSpot is a software medical device that uses images of an infant's head to calculate cranial measurements, including Cranial Index (CI) and Cephalic Vault Asymmetry Index (CVAI). The SoftSpot platform allows users to capture and upload images for analysis and generation of measurement reports. The associated kit includes caps and accessories to support image capture quality. SoftSpot is intended for cranial measurement of infants from 1 month to 2 years of age in conjunction with other clinical methods.

PediaMetrix Inc.

2026-06-07