20 results
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19ms
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Sources: EU EUDAMED, US FDA
AMBULATORY ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169330078·PLATE 3003047 ZEVO 47MM 3 LVL
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663636·PLATE 3003047 ZEVO 47MM 3 LVL
Premier Carvers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009170·CARVER DE 5C
CUSTOMED
FDA UDI
CUSTOMED INC·M20890030477·CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 6.0
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530471·
TRIFECTA
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015280·TRIFECTA NiTiTherm Upper 18x18 10 archwires per...
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
FDA 510(k)
FDA Class 2
·Cardiovascular
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116030·
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024116023·
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·November 17, 2025
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·March 13, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 8, 2011
2250051-2008-00091
FDA Adverse Event
Malfunction
·Product code JTC·February 11, 2008
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·November 10, 2017
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024