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

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VISULAS TRION LASER SYSTEM WITH THE VITE OPTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

SCHROEDER VULSELLUM BONE REDUCTION CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051171·SCHROEDER VULSELLUM BONE REDUCTION CLAMP WITH S...

Oph. Cystotomes

FDA UDI
KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172971185·

AMSINO MEDICAL USA

FDA Adverse Event
Other ·AMSINO MEDICAL USA·Product code FOZ·May 20, 2009

GELCLAIR CONCENTRATED ORAL GEL

FDA 510(k)
FDA Unclassified ·Unknown

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DREAMSTATION

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 14, 2025

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·May 9, 2013

TALENT TAA

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·September 19, 2014

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·PLASTI ESTERIL, S.A. DE C.V.·Product code FKX·May 25, 2011

ARCOS LATERAL TROCH BOLT 42MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 22, 2017

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 14, 2018

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·January 18, 2017

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023