Cardamyst
etripamil
MILES
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004082685 | 3004082685 | MILESTONE SCIENTIFIC, INC. | 1 | N | 2026-01-01 | 425 Eagle Rock Ave. Roseland NJ US 07068 |
| 3009273902 | 3009273902 | MILESTONE MEDICAL TECHNOLOGIES, INC. | 1 | Y | 2026-01-01 | 6475 Technology Ave Ste F Kalamazoo MI US 49009 |
| 3011387907 | 3011387907 | MILES MEDICAL LLC | 1 | N | 2020-04-25 | 97 E Brokaw Rd Ste 310 San Jose CA US 95112 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 52481 | 1216321554 | K992819 | WAND PLUS | EJI | 2000-05-11 |
| 52481 | 2053628136 | K992819 | WAND PLUS | EJI | 2000-05-11 |
| 52481 | 1210050212 | K992404 | THE WAND | FMF | 2000-06-06 |
| 52481 | 1593289176 | K992404 | THE WAND | FMF | 2000-06-06 |
| 52481 | 1448204437 | K961648 | THE WAND | EJI | 1996-07-05 |
| 52481 | 1050287198 | K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | FMF | 2017-06-09 |
| 52481 | 1876191079 | K061904 | COMPUDENT STA | EJI | 2006-08-08 |
| 52481 | 1205376619 | K053554 | COMPUFLO | FRN | 2006-07-10 |
| 52481 | 1779186639 | K023722 | SAFETYWAND DISPOSABLE HANDPIECE | EJI | 2003-09-02 |
| 52481 | 1281663086 | K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | FMF | 2001-06-29 |
| 52481 | 1912844244 | K000393 | NOVA CORDLESS CURING LIGHT | EBZ | 2000-03-27 |
| 178853 | 1568081702 | K000162 | METRISCAN BONE DENSITY SYSTEM | KGI | 2000-05-12 |
Product Codes Associated With Registrations#
NDC#
Non Tinted Mineral Sunscreen
Titanium Dioxide, Zinc Oxide
Tinted Mineral Sunscreen
Titanium Dioxide, Zinc Oxide
Mineral Lip Sunscreen
Titanium Dioxide, Zinc Oxide
Non Tinted Mineral Sunscreen Stick
Titanium Dioxide, Zinc Oxide
Tinted Mineral Sunscreen Stick
Titanium Dioxide, Zinc Oxide
PMA#
BIOSTATOR GLUCOSE CONTROLLER
MILES LABORATORIES, INC.
BIOSTATOR GLUCOSE CONTROLLER
MILES LABORATORIES, INC.
PMN#
CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific, Inc.
CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific, Inc.
MILESMAN PREMIUM
MILESMAN S.L.
COMPUDENT STA
MILESTONE SCIENTIFIC, INC.
COMPUFLO
MILESTONE SCIENTIFIC, INC.
DI-2000
MILES INC., AGFA DIVISION
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
MILES, INC.
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
MILES, INC.
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
MILES, INC.
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
MILES, INC.
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
MILES, INC.
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
MILES INC., DENTAL PRODUCTS
DIGITAL I.D. CAMERA
MILES INC., AGFA DIVISION
OPERA SYSTEM
MILES, INC.
TECHNISON AXON SYSTEM
MILES, INC.
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
MILES, INC.
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM
MILES, INC.
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
MILES, INC.
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
MILES, INC.
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
MILES INC., DENTAL PRODUCTS
CLINISTAT ALBUMIN REAGENT TEST
MILES DIAGNOSTICS DIV.
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
MILES LABORATORIES, INC.
MICRO-BUMINTEST REAGENT TABLETS
MILES LABORATORIES, INC.
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
MILES LABORATORIES, INC.
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
MILES LABORATORIES, INC.
SERALYZER III BLOOD CHEMISTRY ANALYZER
MILES LABORATORIES, INC.
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
MILES LABORATORIES, INC.
CUTTER PUREFLO PLUS IV FILTER
MILES LABORATORIES, INC.
MODIFIED SALTEX REAGENT STRIPS
MILES LABORATORIES, INC.
CIPRO (TM) DIAGNOSTIC POWDER
MILES PHARMACEUTICALS
Potentiating Media For In Vitro Diagnostic Use
Miles, Inc.
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
MILES LABORATORIES, INC.
SERA-TEK MICROSOMAL ANTIBODY TEST
MILES LABORATORIES, INC.
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
MILES LABORATORIES, INC.
SERA-TEK THYROGLOBULIN ANTIBODY TEST
MILES LABORATORIES, INC.
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
MILES LABORATORIES, INC.
GLUCOFACTS DATA MANAGEMENT SYSTEM
MILES LABORATORIES, INC.
GLUCOFACTS DATA PRINTER
MILES LABORATORIES, INC.
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
MILES LABORATORIES, INC.
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
MILES LABORATORIES, INC.
Applications#
GUDID#
CathCheck Disposable Kit - CathCheck Disposable Kit box single pouch, which consists of 1 adaptor,1 pressure transducer to be used with CompuFlo Epidural Computer Controlled Anesthesia System
2025-01-17
CompuFlo Epidural Trainer 110V/220V - CompuFlo Epidural Trainer
2023-06-14
Epidural Trainer Disposable Kit - EPI 6510T CompuFlo Epidural Trainer Disposable Kit
2023-06-14
CathCheck Disposable Kit - CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System
2023-06-14
Epidural Disposable Box - Epidural Disposable Box of 10 units
2023-06-14
Epidural Disposable Kit - Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
2023-06-14
CathCheck Disposable Kit (Pre-assembled) - CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
2023-06-14
Epidural Disposable Kit - Epidural Disposable Kit (pre-assembled)
2023-06-13
CompuFlo Epidural Computer Controlled Anesthesia System - CompuFlo Epidural Computer Controlled Anesthesia System 220V
2023-06-13
CompuFlo Epidural Computer Controlled Anesthesia System - CompuFlo Epidural Computer Controlled Anesthesia System 110V
2023-06-13
CompuDent STA Drive Unit - STA Instrument 220V
2023-06-13
CompuDent-STA™ Drive Unit - STA Instrument 110V
2023-06-12
SAFETY WAND Handpiece - SAFETY WAND Handpiece with needle
2018-01-26
SAFETY WAND Handpiece - SAFETY WAND Handpiece with needle
2018-01-26
SAFETY WAND Handpiece - SAFETY WAND WA Handpiece with needle
2018-01-26
Safety Wand Handpiece - SAFETY WAND WA Handpiece without needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - WA Handpiece without needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece with needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece with needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece with needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece without needle
2018-01-26
the Wand STA Handpiece - STA Handpiece with needle
2018-01-26
the Wand STA Handpiece - STA Handpiece with needle
2018-01-26
the Wand STA Handpiece - STA Handpiece with needle
2018-01-26
the Wand STA Handpiece - STA Handpiece without needle
2018-01-26
CathCheck Disposable Kit - Epidural Disposable Kit
2020-04-20
CathCheck Disposable Kit - Disposable kit to be used with CompuFlo Epidural Computer-Controlled System
2020-04-20
SAFETY WAND Handpiece - SAFETY WAND Handpiece with needle
2018-01-26
SAFETY WAND Handpiece - SAFETY WAND Handpiece with needle
2018-01-26
SAFETY WAND Handpiece - SAFETY WAND WA Handpiece with needle
2018-01-26
SAFETY WAND Handpiece - SAFETY WAND WA Handpiece without needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - WA Handpiece with needle
2018-01-26
the Wand Handpiece - the Wand Handpiece without needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece with needle
2018-01-26
Saftey Wand STA Handpiece - SAFETY WAND STA Handpiece with needle
2018-01-26