14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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740 SELECT
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100097·BARRAQUER SPECULUM SOLID SMALL
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028178·PESSARY, DISH #7, W/O SUPPORT, 85mm
READMYHEART, MODEL RMH3.0
FDA 510(k)
FDA Class 2
·Cardiovascular
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
FDA 510(k)
FDA Class 2
·Cardiovascular
26MM STD V40 TAPER VIT HEAD
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LWJ·June 6, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 22, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
MICRUSFRAME18 7MM X 14.3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
MICRUSFRAME10 7MM X 30CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024