2,741 results · 31ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NTx Urine

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533002936·An enzyme-linked immunosorbent assay (ELISA) fo...

NTx Serum

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533002943·An enzyme-linked immunosorbent assay (ELISA) fo...

VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Osteomark NTx Serum

FDA UDI
Alere Scarborough, Inc.·10811877010941·A test for the quantitative measure of cross-li...

ZEUS NTx Serum

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001861·An enzyme-linked immunosorbent assay (ELISA) fo...

ZEUS NTx Urine

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001878·An enzyme-linked immunosorbent assay (ELISA) fo...

Osteomark NTx Urine

FDA UDI
Alere Scarborough, Inc.·10811877010934·An enzyme-linked immunosorbent assay (EIA) for ...

ZEUS NTx Serum

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533001953·An enzyme-linked immunosorbent assay (ELISA) fo...

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NA

FDA UDI
NIHON KOHDEN AMERICA, INC.·10841983103909·NTX DISPOSABLE POUCH, 100/BOX

OSTEOMARK NTX POC

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OSTEOMARK NTX SERUM EIA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Neuralytix iD3 System (NTX-9001)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Sebia NTx Serum Test System

FDA UDI
ZEUS SCIENTIFIC, INC.·00845533002004·An enzyme-linked immunosorbent assay (ELISA) fo...

NTX

FDA Adverse Event
Malfunction ·NIHON KOHDEN AMERICA, INC.·Product code DRG·September 24, 2010

CNS-6201

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·September 7, 2015

NTX TRANSMITTER

FDA Adverse Event
Malfunction ·NIHON KOHDEN AMERICA, INC.·Product code DRG·August 5, 2016

OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRIATHLON PRIM CEM FXD BPLT #2

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 17, 2014