22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ChoiceSpine Blackhawk Ti Cervical Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
XLP - Toyota - Black - XLPouch
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113288·STAB KNIFE 22.5 DEGREE (BX/5)
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361037033·Trial Rasp, No Stop, Assembly, Straight, 11mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136155·Femoral Sizer Feet, Neutral
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523150489·Distal Femoral Alignment Guide Tower
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523150496·Distal Femoral Cut Block
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149681·Distal Femoral Alignment Guide
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148165·Femoral IM Elevator
NUTRISAFE PUR ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOOP MICROWAVE ABLATION PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2023
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 5, 2021
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 23, 2014
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013
SEE H11 NARRATIVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·November 6, 2025
ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code NCX·June 26, 2025
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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