26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
FDA 510(k)
FDA Class 2
·Orthopedic
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00850038691042·
NIOX MINO MODEL 09-1000
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
FDA 510(k)
FDA Class 2
·Immunology
SEALING UNIT FROM 5MM TROCARS
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
REDUCING CONVERTER 10/12MM TO 5MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·February 4, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·April 13, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·August 6, 2020
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 6, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEATHCARE CORPORATION·Product code KDJ·September 19, 2014
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 18, 2011
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·August 24, 2021
SPACER, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code ODP·August 23, 2019
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·August 17, 2022
SMARTXIDE 50 HS
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023
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