15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ponto 5 Mini
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NuVasive
FDA UDI
Nuvasive, Inc.·00195377105011·NTS Slot Tube, 16x40mm Beveled
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046323·LATERAL IMPLANT, WIDE, STANDARD, 16mm X 23mm X ...
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·October 29, 2014
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 5, 2011
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 8, 2013
FEMORAL HEAD STERILE PRODUCT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 19, 2022
G7 PPS LTD ACET SHELL 56F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 19, 2022
G7 DUAL MOBILITY LINER 44MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·April 19, 2022
SIZE 2 130MM STEM LENGTH 12/14
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·April 19, 2022
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025