17 results · 20ms · Sources: EU EUDAMED, US FDA

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INTRAFIX TIBIAL SHEATH

FDA 510(k)
FDA Class 2 ·Orthopedic

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664010898·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...

EverFlo

FDA UDI
Respironics, Inc.·00606959032781·EverFlo, w/Oxygen Percentage Indicator, 230V, S...

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

FDA 510(k)
FDA Class 2 ·Ophthalmic

COLLAGEN WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 11, 2024

HUT EXT DR FINAL ASSY-REVERSE

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code IXR·May 1, 2013

HEARTSTRING II PROXIMAL SEAL SYSTEM

FDA Adverse Event
Injury ·GUIDANT CARDIAC SURGERY·Product code DXC·August 7, 2008

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 20, 2011

PEEK ROD W/ BASO4, CURVED, 5.5MM X 45 MM

FDA Adverse Event
Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·June 15, 2015

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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

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

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

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

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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