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

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UNO 30

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Greenwald Surgical Company, Inc.

FDA UDI
GRACE MANUFACTURING, INC.·10801334008918·Otis Bougie-a-Boule. Mirror finish, stainless s...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196464·AK3 Patella Resection Guide w/ Offset

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR

Grappler™ Suture Anchor System

FDA UDI
Paragon 28, Inc.·00889795153814·Grappler Suture Anchor System Ø2.8 All-Suture S...

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES

FDA 510(k)
FDA Class 2 ·Ophthalmic

MASIMO RADICAL Y PULSE CO-OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIAC CATHETERIZATION 4-STATION HIGH PRESSURE STOPCOCK MANIFOLD (OFF HANDLES)

FDA Adverse Event
Injury ·Product code DQO·September 23, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 1, 2024

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

RADICAL 7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

RADICAL 7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

RADICAL-7 COLOR SCREEN HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·May 29, 2015

RDS3 DOCKING STATION

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·September 17, 2014

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas® HPV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas® HPV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas® HPV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test