18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VSP SYSTEM
FDA 510(k)
FDA Class 2
·Dental
WeightRight®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020913·Tungsten-Filled Hurst Esophageal Dilator, 56 Fr...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704219·Castroviejo Suturing Forceps 4" (10cm), w/ 11mm...
SPONDY SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
FDA 510(k)
FDA Class 2
·Radiology
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
RESERVOIR 2PK 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 13, 2008
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
ENDURO MENISCAL COMPONENT F1 10MM
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018