10,000 results · 392ms · Sources: EU EUDAMED, US FDA

DIAMOND BLADE SURGICAL KNIVES

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ASFORA ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL

FDA 510(k)
FDA Class 1 ·Microbiology

COMFORT STRAP

FDA 510(k)
FDA Class 1 ·Anesthesiology

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

FDA 510(k)
FDA Class 2 ·Neurology

OCULAR INFUSION CANNULA SYSTEM

FDA 510(k)
FDA Class 1 ·Ophthalmic

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

FDA 510(k)
FDA Class 2 ·Neurology

CINCH

FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071119515·AMT Cinch™ Tube Securement Device

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder

Logiq S8 and transducers: C1-5-D, 9L-D, ML6-15-D, M5S-D, 1C5-9-D, 3CRF-D, L8-18i-D, S4-10-D, C2-9-D, 11L-D, 6S-D

FDA registration
ADVANCED ULTRASOUND ELECTRONICS·3 products·🇺🇸 United States

Glucose Kit (GOD-POD Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Glucose test strip

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·General Life Biotechnology Co., Ltd.·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D

COBAS INTEGRA REAGENT CASSETTES

FDA registration
ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany

Classic

FDA UDI
Mlife Diagnostics, LLC·G474MC001050001EI0·mLife Classic 5 panel oral fluid drug test AMP-...

Verify

FDA UDI
Mlife Diagnostics, LLC·G474MV001050001EI0·mLife Verify 5 panel oral fluid drug test AMP-C...

AirSEP AS-D+

Basic UDI-DI
EU MDD · Eu Md Class 2a ·CAIRE Inc.·1 device

Sharay ASD (CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

OEC One ASD

Basic UDI-DI
EU MDR · Eu Md Class 2b ·GE HUALUN MEDICAL SYSTEMS CO. Ltd·1 device

CSD Smart Plate

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Carestream Dental LLC·5 devices