27 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.

HEMA SCREEN ER

FDA 510(k)
FDA Class 2 ·Hematology

ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

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

HARDYDISK LEVOFLOXACIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

2.4MM VA LOCKING SCREW STARDRIVE 22MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·June 25, 2013

AMISTEM H CEMENTLESS FEMORAL STEM SIZE 2 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 4, 2015

QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

OXYGENATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

OXYGENRATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

V SERIES MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·May 1, 2013

BATTERY OSCILLATOR II FOR BPL II

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·September 19, 2014

TERUMO CDI 100 MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·May 23, 2011

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. 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