22 results · 23ms · Sources: EU EUDAMED, 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