12 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

E320 OTP Delivery System

FDA UDI
Engle Dental Systems, LLC·00850043433262·Utility Center Mounted Dr. & Asst E300 Delivery...

TraXis®

FDA UDI
ZIMMER SPINE, INC.·00889024332829·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16710030709250·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197541329·Ferreira Style Breast Retractor 70x25m...

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E

FDA 510(k)
FDA Class 2 ·Anesthesiology

CARBODISSECTING ENDOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 16, 2026

UNKNOWN TRIATHLON PRIMARY FEMUR

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 19, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·April 22, 2013

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2008

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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