3,971 results
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48ms
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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