15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
FDA 510(k)
FDA Class 1
·Orthopedic
OnBrace Crown UR8 w/ AWT (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199014200·
20 DEGREE PRISM LENS
FDA UDI
KATENA PRODUCTS, INC.·00841668112434·
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981140571·Tissue Retractor
Vu a-POD Prime NanoMetalene
FDA UDI
Seaspine Orthopedics Corporation·10889981126780·Prime NM Implant, 39x30mm x 14mm, 20 Deg
SLIDESCAN
FDA 510(k)
FDA Class 2
·Hematology
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 15, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
IMPACT LIP-LOC ACETABULAR LINER 28 MM NEUTRAL / HI-WALL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 17, 2010
HEARTSTAREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 2, 2013
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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