32 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEO-SERVO I
FDA 510(k)
FDA Class 2
·General Hospital
Nezhat-Dorsey
FDA UDI
Davol Inc.·00801741065385·Nezhat-Dorsey Trumpet Valve, with 5mmx33cm Prob...
Radius Plate PROlock, Small
FDA UDI
I.T.S. GmbH·09120034304330·Radius Plate PROlock, Small, 10-Hole, Right
Tasso Mini
FDA UDI
Tasso Inc.·00850038691134·
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
SYRINGE 10ML SHORT PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 3, 2021
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837051174·
Endo-Model Standard Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575194667·Replacement Set, with anti-luxation device
T-PLUS™* PEEK VBR/IBF SYSTEM
FDA UDI
Pioneer Surgical Technology, Inc.·00846468032517·T-Plus, 10X27X10
T-Plus PEEK IBF System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468033996·INTERBODY FUSION DEVICE
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786026·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786194·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786118·
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 19, 2011
GALAXY G3 4MM X 12CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2022
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