17 results · 19ms · 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.

CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE

FDA 510(k)
FDA Class 2 ·Neurology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496031482·RELAX UNISEX 140 OPEN TOE, SIZE L, BLU SCURO, G...

AURENORM 75 KF

FDA 510(k)
FDA Class 2 ·Dental

DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

FDA 510(k)
FDA Class 1 ·General Hospital

SECURE 3 MED/SURG BEDOBS 01/13

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013

POSEY STAYSAFE BED

FDA Adverse Event
Malfunction ·J. T. POSEY CO.·Product code FNL·March 18, 2011

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

FDA Adverse Event
Other ·STAAR SURGICAL·Product code HQL·April 18, 2008

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 25, 2023

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

FDA Enforcement
Class II ·Ongoing·Canary Medical, Inc.·July 16, 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

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012