16 results
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20ms
·
Sources: EU EUDAMED, US FDA
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496060079·PYRAMID 70, SIZE M, NERO, GRADUATED COMPRESSION...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0600090·Tray Insert, Level II
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0600090·Tray Insert, Lumbar Instruments, 1
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0600090·Tray Insert, Disc Prep 2
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·January 17, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·January 17, 2019
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 9, 2024
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·April 11, 2013
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 15, 2011
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 20, 2023
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024