9 results · 21ms · Sources: EU EUDAMED, US FDA

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SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

FDA 510(k)
FDA Class 2 ·Ophthalmic

PASS LP SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GC FUSION

FDA 510(k)
FDA Class 2 ·Dental

K-WIRE, RECON 3.2X400 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 13, 2012

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·November 10, 2014

EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 9, 2011

GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·July 22, 2013

PKG, BLAKESLY BIOPSY FORCEPS, P/N 0250080292. 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

Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw

FDA Enforcement
Class II ·Ongoing·Acumed LLC·January 4, 2023