FDA.reportPublic FDA data

AMBI, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080616173008061617AMBI, INC.1N2026-01-01908 Sir Francis Ave. Capitola CA US 95010
30106923333010692333Ambient Clinical Analytics1N2026-01-01221 1st Ave Sw Ste 600 Rochester MN US 55902

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
00025294874007Inject-Ease - Holder for disposable syringes that hides the needle and makes self-injections easier831-475-1765info@ambimedinc.com
00860000561907GuideBlade - Sterile GuideBlade516-766-3800ari@ambitusmedical.com
00860000561914GuideBlade - GuideBlade, non-sterile, intended for inclusion in kits516-766-3800ari@ambitusmedical.com
20860000561918GuideBlade - GuideBlade, non-sterile, intended for inclusion in kits516-766-3800ari@ambitusmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1087461746682470K942810PALCO LABS COLD POUCHLDQ1995-06-28
1087461996774968K872233INJECT-EASEKZH1987-09-04
1818411031871576K143372AWAREMWI2015-04-02
1087461020051767
1087461110020545
1087461238466731

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI12015-04-02
LDQ11995-06-28
KZH11987-09-04

NDC#

PMN#

AWARE

2015-04-02

AMBIENT CLINICAL ANALYTICS

Applications#

GUDID#