19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GEON DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040072608·Steel Bur RA 7
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964022645·The ENDO CARRY-ON Procedure Kit contains all of...
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020624·CELL-BOND Slide, 1 Red well, no background
REEF L
FDA UDI
Seaspine Orthopedics Corporation·10889981322083·M/L Angled Lateral Cobb, Inferior, 23mm
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
FDA 510(k)
FDA Class 2
·Anesthesiology
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
ACULUX, MODEL AX3001, AX3002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 8, 2020
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·October 22, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
AXIOM ARTIS ZEE
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IZI·February 28, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·February 21, 2008
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024