3,971 results · 48ms · Sources: EU EUDAMED, US FDA

RETROX

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

HEM-AVERT PERIANAL STABILIZER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NUCLEUS-X PTV CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

FDA 510(k)
FDA Class 2 ·Neurology

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)
FDA Class 2 ·General Hospital

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)
FDA Class 2 ·Microbiology

RESTLESS LEG DEVICE

FDA 510(k)
FDA Class 1 ·Physical Medicine

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)
FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)
FDA Class 2 ·Immunology

DIAMOND PROBE/PERIO 2000 SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NRS Healthcare

Authorized representative
1 Manufacturer·2 Devices

1839/MDD

Certificate
MDD Annex II (excluding section 4)·NSK Dental Italy S.r.l.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·2 Basic UDI-DIs

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS

Sterilizable Handles

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761967267·Sterilizable Camera Handle, 1 pc

Sterilizable Handles

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761967274·Sterilizable ALC Handle, 1 pc

Sterilizable Handles

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761967250·Sterilizable Central Handle, 1 pc

Sunoptic Technologies

FDA UDI
SUNOPTIC TECHNOLOGIES LLC·M678TX0·Tx series Xenon Lightsource

M&S Technologies Smart System® 20/20

FDA UDI
The Hilsinger Company Parent LLC·00850040295566·M&S Technologies Smart System® 20/20

RQS Wojciech Roman

Authorized representative
🇵🇱 Poland·4 Manufacturers