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

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C2 Cryoballoon Ablation System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II

OsteoMed

FDA UDI
OSTEOMED LLC·00845694004534·0.9mm Pilot Drill, Logic Jr, J-Latch

VACUTRON

FDA UDI
Allied Medical, LLC·00026072009192·INTERMITTENT SUCTION REGULATORS

SURGICAL TISSUE MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

REVERE STABILIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

TRIATHLON PS FEM COMPONENT, CEMENTED

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 8, 2011

ACCU-CHEK COMPACT PLUS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code NBW·September 15, 2008

TRILOGY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

G7 VIVACIT-E

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

G7 OSSEOTI

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

TRILOGY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025

VIDAS® TOXO IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LYR·December 7, 2016

VIDAS® TOXO IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LYR·December 5, 2016

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 23, 2020

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017

Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

FDA Enforcement
Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022