92 results · 21ms · Sources: EU EUDAMED, US FDA

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Cranial Electrotherapy Stimulator To Treat Depression

FDA Pre-Market Approval
FDA Class 3 ·Flow FL-100

PRO ADVANTAGE

FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P2300233·PRO ADVANTAGE PILLOWCASE 21X30 T/P 100/CS

UNIFY PP Surgical Sutures

FDA UDI
APPLIED DENTAL, INC.·00814639023343·Polypropylene Suture, Non-absorbable, Size 2/0,...

LEONE SPA

FDA UDI
LEONE SPA·08033707022831·CALIBRA BANDS 2ND MOLAR n.SUL 24

HI-EMT MAGSHAPE

FDA 510(k)
FDA Class 2 ·Physical Medicine

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATETER

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR

ALTIUS SYSTEM

FDA Adverse Event
Malfunction ·NEUROS MEDICAL INC.·Product code LGW·April 2, 2025

ALTIUS SYSTEM

FDA Adverse Event
Malfunction ·NEUROS MEDICAL INC.·Product code LGW·June 20, 2025

STARCLOSE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 12, 2008

ACCESS

FDA Adverse Event
Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·August 31, 2011

ALARIS SE PUMP

FDA Adverse Event
Injury ·CAREFUSION CORPORATION·Product code FRN·July 10, 2013

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix Drug Coated Ballon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER