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FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
FDA Enforcement
Class II
·Terminated·Ohmeda Medical·March 29, 2017
13.5CM ANGLE ATTACHMENT, BLACK MAX
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Enforcement
Class II
·Terminated·Cardinal Health·April 3, 2013
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·May 10, 2017
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
FDA Enforcement
Class I
·Ongoing·Medtronic Inc.·February 19, 2020
5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 29, 2017
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
FDA Enforcement
Class II
·Terminated·Candela Corporation·October 30, 2019
Console, eMax2 Plus Product Usage: Electric system
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·May 10, 2017