182 results · 29ms · Sources: EU EUDAMED, US FDA

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RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743694·ACHIMED ACHILLES SUPP SILVER VI

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540602610·Bone Screws, MP, Cross-Pin

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837026431·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837009946·

VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

CAROTID WALLSTENT MONORAIL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·March 16, 2011

DEXTRUS 4135

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008

Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026