22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENTRIO ST HERNIA PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARGENCO 10
FDA UDI
ARGEN CORPORATION, THE·D818101920·Gold based noble metal
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00850038691028·
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG
Schott Eye Speculum
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896122420·Schott Eye Speculum With Rotatable Level Adjust...
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·B887MR05001019200·0.5mm x 1.0cm VISICOIL MR Platinum loaded in an...
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WAKO AUTOKIT LP(A)/ RA,500/1000,
FDA 510(k)
FDA Class 2
·Immunology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013
QUICKSET 1PC FLEX DRILL BIT 35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·September 19, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 18, 2011
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
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021