19 results · 20ms · Sources: EU EUDAMED, US FDA

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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