16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042778·RELAX UNISEX 70, SIZE XXL, BIANCO, GRADUATED CO...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809870084·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
FDA 510(k)
FDA Class 2
·Orthopedic
ENTERIC INJECTION CATHETER WITH IRRIGATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARMONIC ACE 36 CM
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005
TSRH® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016
TSRH® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016
DEPUY PINNACLE ALTRX NEUTRAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC·Product code LPH·April 4, 2013
ACTIVE® INHIBIN A ELISA, 4X96 WELLS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code NDR·April 7, 2011
VITALITY 2 VR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 16, 2017
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
PKG, 5MM X 33CM INSERT, DISSECTING FORCEPS, P/N 0250080760 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019