27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
FDA 510(k)
FDA Class 2
·Microbiology
MaXcess
FDA UDI
Nuvasive, Inc.·00887517197191·MaXcess 4 Blade, 110mm Left
SpheRx
FDA UDI
Nuvasive, Inc.·00887517443137·SpheRx® II Hook, 6mm Reduced Tip Narrow
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704515138·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022682·FPS 2.7mm 6 Hole L Plate Right
2.0/2.4MM FRACTURE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036036072·PLATE HOLDING FORCEPS
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78824111000201·EXRC MBT 018/UR1 17T 4A
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076944·FPS 2.7 6 Hole Right L Plate Sterile Qty 2
MB 105 MILLENNIUM BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
CRYOCARE CS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMS INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·June 3, 2019
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·November 21, 2008
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013
MICROCLAVE¿ CLEAR CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025
BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2019
CLARISSE ONE STEP HCG PREGNANCY TEST
FDA Adverse Event
Malfunction
·WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD·Product code LCX·July 22, 2025
CLARISSE ONE STEP HCG PREGNANCY TEST
FDA Adverse Event
Malfunction
·WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO.,LTD·Product code LCX·July 22, 2025
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020