107 results · 16ms · 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.

Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.

FDA Recall
Terminated ·Plus Orthopedics USA·Product code KTT·February 22, 2006

Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

FDA Recall
Terminated ·Bard Access Systems·Product code IYN·June 21, 2011

HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

FDA Recall
Terminated ·Porous Media Corporation·Product code BTT·April 26, 2007

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

FDA Recall
Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·March 21, 2014

Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·November 9, 2017

BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

FDA Recall
Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014

Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

FDA Recall
Terminated ·Respironics California Inc·Product code CBK·October 29, 2014

Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

FDA Recall
Open, Classified ·Abiomed, Inc.·Product code OZD·April 20, 2026

Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KKX·January 7, 2016

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

FDA Recall
Open, Classified ·HUMAN MED AG Wilhelm-Hennemann-Str. 9 Schwerin Germany·Product code QPB·October 18, 2024

Xoran MiniCAT CT Scanner ID ENT00001

FDA Recall
Terminated ·Xoran Technologies, Inc.·Product code JAK·December 14, 2009

NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

FDA Recall
Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·December 17, 2007

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

FDA Recall
Terminated ·Alpha Omega Engineering·Product code GZL·September 4, 2018

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015

ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

FDA Recall
Terminated ·Sendx Medical Inc·Product code CHL·June 19, 2007

HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

FDA Recall
Open, Classified ·Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China·Product code QMC·July 12, 2022