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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004

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

Zethon

FDA UDI
ZETHON LIMITED·05059358050378·STERILE IRRIGATION TUBE KIT - C SHANK, SLIMLINE

Sklar®

FDA UDI
SKLAR CORPORATION·10649111367762·MAYO TRAY PERF191/8X125/8X3/4"

Sklar®

FDA UDI
SKLAR CORPORATION·30649111253328·MAYOTRAYPERF191/8X125/8X3/4PK6

Sklar

FDA UDI
SKLAR CORPORATION·30649111208809·MAYO TRAY PER 191/8X125/8 PK12

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PELVICFLEXER EXERCISE DEVICE

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

HEARTMATE 3 SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·July 12, 2023

IMP,TSV,4.7,11.5,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 8, 2022

SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·February 24, 2010

SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MQQ·February 24, 2010

SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·February 24, 2010

INTERSTIM IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MQQ·February 24, 2010

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS(SLC)·Product code JAA·April 30, 2013

INFINITI VISION SYSTEM

FDA Adverse Event
Injury ·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·September 15, 2014

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 10, 2011

IMP,TSV,MCOL MG,4.7MM,10M

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·September 15, 2022

UNK HIP FEMORAL STEM CORAIL

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 9616671·Product code LZO·July 19, 2022

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024