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

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Diapex Plus

FDA 510(k)
FDA Class 2 ·Dental

Bioseal Inc.

FDA UDI
BIOSEAL·00630094018263·Drape Fenestrated Polylined STERILE

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122292·Kwire .070X9" (1.8x225mm)

VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03

FDA 510(k)
FDA Class 2 ·Anesthesiology

SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

CADD LEGACY 1 PUMPS 6400

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·February 3, 2023

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019

PLATE,FIXATION,BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

TERUMO CDI 540 CALIBRATOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·July 5, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 21, 2013

SOLETRA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code MHY·July 23, 2008

Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450

FDA Recall
Terminated ·Steris Corporation·Product code GDC·February 6, 2007

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021