23 results
·
20ms
·
Sources: EU EUDAMED, US FDA
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
FDA 510(k)
FDA Class 2
·Ophthalmic
Zavation
FDA UDI
Zavation LLC·00842166180673·Guidewire
Zavation
FDA UDI
Zavation LLC·00842166189232·AWL A-O ATTACHMENT
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109218·DB BKT MINI MS UL CEN 018 T+12 A+5 R=0
Integrity Orthopaedics
FDA UDI
Integrity Orthopaedics, Inc·00860013905941·Tendon Seam™ Magazine - 8 Anchor
BIRMINGHAM HIP
FDA UDI
Smith & Nephew, Inc.·03596010504647·BIRMINGHAM HIP SHORT ALIGNMENT PIN
Integrity Orthopaedics
FDA UDI
Integrity Orthopaedics, Inc·00860009782235·Integrity Orthopaedics Anchor Array
ORTHOPANTOMOGRAPH OP 3D Pro
FDA UDI
PaloDEx Group Oy·06430035872732·
Rampart One Lumbar Interbody Fusion Device
FDA UDI
SPINEOLOGY INC.·M7404901002·Rampart One Standard Spacer
MIRACLE SUCTION,MINI KIT
FDA UDI
DiaDent Group International·08806383524346·Multifunctional Mirror with Suction
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
FDA 510(k)
FDA Class 2
·Cardiovascular
WAKO LIPASE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Truliant
FDA UDI
Exactech, Inc.·10885862604781·
PORTEX LINE DRAW PLUX W/ DRY LITHIUM HEPARIN AND FILTER-PRO
FDA Adverse Event
Injury
·SMITHS MEDICAL, INC.·Product code JKA·June 17, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 17, 2010
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·December 13, 2012
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 8, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021