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

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PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE

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

VANGUARD REPROCESSED PHACOEMULSIFICATION

FDA 510(k)
FDA Class 2 ·Ophthalmic

STCC

FDA 510(k)
FDA Class 2 ·Orthopedic

BLAKE DRAIN

FDA Adverse Event
Malfunction ·ETHICON·Product code KOG·June 3, 2011

2.4MM VA LOCKING SCREW STARDRIVE 22MM

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

CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022

VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

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

PLMA DVC V11.51 1 R

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 19, 2014

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·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

Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106

FDA Enforcement
Class II ·Terminated·ConvaTec, Inc·June 14, 2017

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

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

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

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021