15 results
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35ms
·
Sources: EU EUDAMED, US FDA
CHLAMYDIA OIA
FDA 510(k)
FDA Class 1
·Microbiology
BASE
FDA UDI
Nuvasive, Inc.·00887517700575·BASE Ti Implant, 10x34x24mm 10°
Gelseal™ Cardiovascular Patch
FDA UDI
VASCUTEK LTD·05037881010427·Gelseal Gelatin Impregnated Knitted Cardiovascu...
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295230212·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP...
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112250·SURG-I-BAND YELLOW
OSTEOTOME, 10MM
FDA UDI
BIOPRO, INC.·00810012482981·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867061729·UNIVERS REVERS RASP/TRIAL STEM- SIZE 10
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127023781·70 Degree Retractor
Piccolo Composite Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
FDA 510(k)
FDA Class 2
·Dental
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·February 8, 2013
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·July 22, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017