27 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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UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
LEONE SPA
FDA UDI
LEONE SPA·08033707011323·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 10
Symmetry Beebee
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482173930·Symmetry® Scissors, Beebee Wire, Curved, Serrat...
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277101150·Cheng Large Trephine
Zinnanti Surgical
FDA UDI
Zinnanti Surgical Design Group Inc·G3731425100·6" Smoke Evac Fusion 25mm x 10mm Loop
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101925·Poly Insert MPCS, Size 5L, 10mm
ICRCO 3600M
FDA 510(k)
FDA Class 2
·Radiology
DIMENSIONS HB1C KIT, MODEL DF105A
FDA 510(k)
FDA Class 2
·Hematology
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2025
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962110829·BEEBEE WIRE SCISSORS, 4", SERRATED, CVD
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376668086·12mm CORE, NANOTEC KBN 14 x 25 mm 10°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376667652·12mm CORE, NANOTEC BAN 14 x 25 mm 10°
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 16, 2018
R3 PRIMARY LINERS CO
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·October 6, 2014
ETS FLEX ARTICNG LNR CUTR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 28, 2011
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025