19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3L SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
ZAVATION
FDA UDI
Zavation LLC·00842166154551·WHITNEY 4deg 30mmx15mm
ZAVATION
FDA UDI
Zavation LLC·00842166156777·HA+ ALIF 4deg 30mmx15
Zavation
FDA UDI
Zavation LLC·00842166121300·ALIF 4deg 30mm x 15mm
Zavation
FDA UDI
Zavation LLC·00842166180222·ALIF Sizer 4deg 30mm x 15mm
Implant-One
FDA UDI
Implant Logistics, Inc.·D762APT0430150·Abutment, 400 Series Angled Post 3mm Cuff Heigh...
CARDIS
FDA 510(k)
FDA Class 2
·Cardiovascular
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·March 7, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 25, 2011
VITALITY DR HE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 13, 2020
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 15, 2020
PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·April 14, 2021
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
FDA Enforcement
Class II
·Ongoing·ETAC A/S·February 11, 2026
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017