17 results · 23ms · Sources: EU EUDAMED, US FDA

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PCP-USB STETHOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606067·SPACER 2132560 OLIF25 27MM 12 DEG 16X60

RC Screw-retained Abutment

FDA UDI
BIO CONCEPT Co., Ltd.·06947600381204·

Bernafon

FDA UDI
Bernafon AG·05711584050873·CA5 ITC, R BE CARISTA 5

CASTROVIEJO CORNEAL SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014428·CASTROVIEJO CORNEAL SCISSORS STRONG CURVED BLADE

AXOGUARD NERVE CONNECTOR AND PROTECTOR

FDA Adverse Event
Injury ·COOK BIOTECH·Product code JXI·August 24, 2015

ARROWHEAD SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REPROCESSED PULSE OXIMETER SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 27, 2021

ACCU-CHEK ® TENDER INFUSION SET

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·October 1, 2014

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 29, 2013

TI LCP DISTAL FEMUR PLATE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·June 10, 2011

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

FDA Adverse Event
Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

AXOGUARD NERVE CONNECTOR AND PROTECTOR

FDA Adverse Event
Injury ·COOK BIOTECH·Product code JXI·October 24, 2019

INTELLIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 12, 2025

OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

FDA Enforcement
Class II ·Terminated·Osteomed, LLC·June 10, 2020

OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

FDA Enforcement
Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020