22 results · 21ms · 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.

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LIEBERMAN SPECULUM

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072220·LIEBERMAN SPECULUM WITH BEADS TEMPORAL APPROACH...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111375972·INSTR TRAY 12.75 X 6.875 X 2.5

Sklar

FDA UDI
SKLAR CORPORATION·30649111258712·INSTR TRAY 123/4X67/8X21/2PK12

Sklar®

FDA UDI
SKLAR CORPORATION·30649111334171·INST TRAY 12.75X6 7/8X2.5 PK 6

HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

OLYMPUS ENDOSCOPIC LIGATION DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PASSEO-18 5/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 6/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 2.5/170/130

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 3, 2013

ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code MPA·May 10, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 7, 2008

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 30, 2020

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

Model Number U128, VALITUDE CRT-P EL MRI

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021