19 results · 21ms · Sources: EU EUDAMED, US FDA

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Nexxt Matrixx System

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517576378·CoRoent Ant TLIF Ti, 9x11x40mm 8°

Orthos

FDA UDI
ORMCO CORPORATION·00889989030037·ORTHOS CM SST 016 X 022 UPLG PK10

Life Instruments

FDA UDI
Life Instrument Corporation·M930719140830·Custom Teardrop Curette 8mm 50° Lateral Angle

Life Instruments

FDA UDI
Life Instrument Corporation·M930719140810·Custom Teardrop Curette 8mm 20° Fwd Angle

Life Instruments

FDA UDI
Life Instrument Corporation·M9307191408300·Custom 6.5mm Lateral Ang Teardrop Curette w/4.5...

Life Instruments

FDA UDI
Life Instrument Corporation·M9307191408100·Custom 6.5mm Teardrop Curette w/4.5" Handle

MICROGARD II

FDA 510(k)
FDA Class 2 ·Anesthesiology

DISPOSABLE PRESSURE TRANSDUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·July 1, 2015

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

SIMPLEX P-JAPANESE TWIN PACK

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·July 28, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 26, 2013

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008

UNK HIP FEMORAL STEM SROM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022

UNK HIP FEMORAL SLEEVE SROM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016