28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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