22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTICOAT MOISTURE CONTROL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Avitene
FDA UDI
Davol Inc.·00801741010538·Avitene Ultrafoam, 8 cm x 6.25 cm (3-1/8" x 2.5...
Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989025415·PREF.LING.ARCH NI-TI LO18 SZ2 PK/10
LATERALIZED AND AUGMENTED BASEPLATE
FDA UDI
FX SOLUTIONS·03701037316818·TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/H...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410500300·Anterior Closing Wedge Osteotomy Guide, 50mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420500300·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400500300·Anterior Dome Osteotomy Guide, 50mm x 30mm
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311374·
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 24, 2022
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
FDA Enforcement
Class II
·Ongoing·Davol, Inc.·April 29, 2026
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 10, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 31, 2011
*
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 8, 2008
2.7 DEGREE ANGLED SAGITAL SAW
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 28, 2018
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
FDA Recall
Open, Classified
·Davol, Inc.·Product code LMF·March 25, 2026
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024