15 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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