19 results · 31ms · Sources: EU EUDAMED, US FDA

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Tranberg CLS Laser Applicator

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

2730 2WAY NRBV

FDA UDI
HANS RUDOLPH, INC.·00817136026732·2730 LESS MPORT 22MM OD EXH

Puget Sound Energy - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)

VOCOM SILICONE SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

FDA 510(k)
FDA Class 2 ·Orthopedic

CERTAIN® GOLD-TITE® HEXED SCREW

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·June 18, 2019

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·August 7, 2019

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 3, 2025

UNKNOWN DEPUY HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·October 16, 2008

ACUVUE 2 BRAND CONTACT LENSES

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·June 28, 2013

IAB: 8 FR - 30 CC FOS

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·August 3, 2011

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·September 20, 2023

SURGICEL ABSORBABLE HEMOSTAT

FDA Adverse Event
Injury ·ETHICON INC.·Product code LMF·July 9, 2018

PROXIMATE*PPH PROCEDURE SET

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2018

PROXIMATE*HCS HEMORR CIR STAPL

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2018

Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021