32 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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deepLive
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Sbo Hearing A/S·05714464056668·BERNAFON ALPHA 3 MNR T MAC
Orfit Industries
FDA UDI
Orfit Industries NV·05420028705278·10 (pcs.) Bags for Thermofit 32392
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319745281·Wylie Deep Pelvic Retractor, hollow handle, 10"...
devemed
FDA UDI
devemed GmbH·04061644017218·Caliper "Castroviejo" | 9 cm
straight / 0-15 mm
ESMARCH HEAVY BANDAGE SHEARS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026865·ESMARCH HEAVY BANDAGE SHEARS
Reicodent
FDA UDI
devemed GmbH·04061644052431·Caliper "Castroviejo" | 9 cm
straight / 0-15 mm
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
FDA 510(k)
FDA Class 1
·General Hospital
VERSA-DIAL HUMERAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TESS GLENOID REVERSE HEAD DIAMETER 36
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
TWIST DRILL FOR 1.5MMX 4MM SCW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
FDA Enforcement
Class II
·Ongoing·MICROVENTION INC.·May 20, 2026
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 9, 2024
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 22, 2025
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020