5,388 results · 35ms · 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.

MEDSTOCK PTY LTD

FDA registration
MEDSTOCK PTY LTD·1 product·🇦🇺 Australia

Needle (various)

FDA registration
FIELD ORTHOPAEDICS·1 product·🇦🇺 Australia

Mira Voice

FDA registration
LARONIX PTY LTD·1 product·🇦🇺 Australia

BODY COMP ANALYZER, IMP SFB7

FDA registration
Impedimed Limited·1 product·🇦🇺 Australia

Specific Diagnostics

Manufacturer
🇺🇸 United States·1 Importer

Nucleix

Manufacturer
🇮🇱 Israel

Sanway Gene Tech. Inc.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPD; RELIA IPG.

FDA Pre-Market Approval
PD-L1 IHC 28-8 pharmDx

Clearblue® Early Digital Pregnancy Test

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Clearblue ® Early Pregnancy Test

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

One Step Pregnancy Test

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Clearblue® Early Detection Pregnancy Test

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

IDS-iSYS Cartridge Check System (CCS)

FDA registration
Immunodiagnostic Systems SA·1 product·🇧🇪 Belgium

IDS-iSYS 25 VitDS

FDA registration
IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS·2 products·🇫🇷 France

BladeFlask UNIVERSAL

FDA registration
QLICKSMART PTY., LTD.·1 product·🇦🇺 Australia