20 results · 24ms · Sources: EU EUDAMED, US FDA

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EliA SymphonyS Immunoassay

FDA 510(k)
FDA Class 2 ·Immunology

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319741849·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804885·Robotti Rib Elevator Set (Left and Right)

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101087·HELVESTON "BARBIE" RETRACTOR

Life Instruments

FDA UDI
Life Instrument Corporation·M930719071000·Teardrop Curette Small

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 23, 2020

ROLL-X GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MERCURY CPAP

FDA 510(k)
FDA Class 2 ·Anesthesiology

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 7, 2020

TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT COLLLARLESS

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code KWY·October 6, 2008

MOSAIQ

FDA Adverse Event
Malfunction ·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 24, 2013

TOTALCARE BARIATRIC

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 29, 2011

Alinity i TSH Reagent Kit, List Number 07P4830

FDA Enforcement
Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

GALAXY G3 4MM X 12CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2022