17 results · 22ms · Sources: EU EUDAMED, US FDA

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NuVasive Modulus ALIF System

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319707029·Rubin Dorsal Osteotome 7" (17.5cm), 10mm wide

THINKINGNET

FDA 510(k)
FDA Class 2 ·Radiology

MAESTRO WRIST PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·July 13, 2017

PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 22, 2008

RESERVOIR 1.8 ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 11, 2011

SWEET PICOTIP

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007

ATTUNE REV FEM CTT TRL SZ 6 R

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LXH·December 12, 2023

CEFALY

FDA Adverse Event
Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

CEFALY

FDA Adverse Event
Injury ·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026

BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015