66 results · 16ms · Sources: EU EUDAMED, US FDA

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CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.

FDA Recall
Terminated ·Remington Medical Inc.·Product code GDM·April 6, 2009

GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

FDA Recall
Open, Classified ·Agiliti Health Ellis·Product code FNM·January 21, 2026

Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

FDA Recall
Terminated ·Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China·Product code FNM·April 15, 2021

Stryker Arise 1000EX mattress, Part Number 2236000000

FDA Recall
Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FNM·October 31, 2025

Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

FDA Recall
Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·November 1, 2023

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

FDA Recall
Terminated ·American National Mfg Inc·Product code FNM·July 11, 2016

Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

FDA Recall
Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.

FDA Recall
Terminated ·Encompass Therapeutic Support Systems dba BG North America·Product code FNM·March 5, 2010

Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

FDA Recall
Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)

FDA Recall
Open, Classified ·Turncare, Inc·Product code FNM·August 10, 2023

Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.

FDA Recall
Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

FDA Recall
Terminated ·SCM True Air Technologies LLC·Product code FNM·March 18, 2014

Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II, Secure II/3, InTouch, and Epic II 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.

FDA Recall
Terminated ·Stryker Medical Division of Stryker Corporation·Product code FNM·December 3, 2015

VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

FDA Recall
Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

FDA Recall
Terminated ·Atlas Spine, Inc.·Product code MQP·July 26, 2013

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

FDA Recall
Terminated ·Abbott Laboratories·Product code JJX·April 30, 2014

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

FDA Recall
Open, Classified ·mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium·Product code KNN·November 28, 2023

Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

FDA Recall
Terminated ·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015