23 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k)
FDA Class 2
·Immunology
HHM
FDA UDI
Oticon A/S·05707131354860·G500 SC, MINIRITE 312 2.4G C045 HHM
NA
FDA UDI
Synthes GmbH·10886982142825·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Navajo Tribal Utility Authority - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017780·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
FDA 510(k)
FDA Class 2
·Cardiovascular
POROCOAT PRODIGY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
MATRIX2 SOFT 360 SR COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION·Product code HCG·October 15, 2008
RESTORE PRIME
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 5, 2011
PINN LNR CON +4 NEUT 32IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWZ·July 2, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 20, 2012
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 29, 2012
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 5, 2012
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023
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