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Sources: EU EUDAMED, US FDA
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FDA Recall
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BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HTW·November 10, 2006
Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·March 3, 2011
Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·March 3, 2011
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
FDA Recall
Terminated
·Zimmer Biomet Spine, Inc·Product code MAX·March 16, 2017
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·November 17, 2008
Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CGA·November 6, 2009
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
FDA Recall
Open, Classified
·MicroSurgical Technology Inc·Product code HNF·September 17, 2024
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
FDA Recall
Open, Classified
·Product code JIN·October 2, 2023
Victory Motorized Vehicle, 3 wheel Model SC1600
FDA Recall
Terminated
·Pride Mobility Product Corp·Product code INI·July 1, 2004
Victory Motorized Vehicle 4 wheels Model SC1700
FDA Recall
Terminated
·Pride Mobility Product Corp·Product code INI·July 1, 2004
Chauffeur Powered Scooters.
FDA Recall
Terminated
·Electric Mobility Corp·Product code INI·February 7, 2003
Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F. Electronic Mobility Corporation, 599 Mantua Blvd, One Mobility Plaza, Sewell, NJ 08080
FDA Recall
Terminated
·Electric Mobility Corp·Product code INI·March 22, 2007
Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue
FDA Recall
Terminated
·Medline Industries Inc·Product code INI·July 20, 2006
Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue
FDA Recall
Terminated
·Medline Industries Inc·Product code INI·July 20, 2006
Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan.
FDA Recall
Terminated
·Electric Mobility Corp·Product code INI·September 27, 2010
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code INI·November 26, 2010
Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
FDA Recall
Terminated
·Medline Industries Inc·Product code INI·July 20, 2006
Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan.
FDA Recall
Terminated
·Electric Mobility Corp·Product code INI·September 27, 2010
Rascal Powered Scooters.
FDA Recall
Terminated
·Electric Mobility Corp·Product code INI·February 7, 2003