44 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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