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

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FDA 510(k)
FDA Class 2 ·Orthopedic

SPIRA®-A Integrated

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020670·SPIRA®-A Integrated,Trial, 28x38mm, 20° Lordoti...

ProCinch, QuadCinch

FDA UDI
RIVERPOINT MEDICAL, LLC·00840277402943·Adjustable Loop Implant - With Button

CLINCARE LATEX SURGEON'S GLOVE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

RADIANALYZER, MODEL 12710

FDA 510(k)
FDA Class 2 ·Cardiovascular

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 22, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 18, 2011

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

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

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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