45 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OTI BONE CEMENT PLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MirageTM
FDA UDI
Micro Therapeutics, Inc.·00847536004795·103-0608 MIRAGE
Mirage
FDA UDI
Micro Therapeutics, Inc.·00763000518912·GUIDEWIRE 103-0608 V09 MIRAGE MDR
MirageTM
FDA UDI
Micro Therapeutics, Inc.·00847536004788·103-0608 MIRAGE
Mirage
FDA UDI
Micro Therapeutics, Inc.·00763000294120·GUIDEWIRE 103-0608 V08 MIRAGE
MirageTM
FDA UDI
Micro Therapeutics, Inc.·00847536004801·103-0608 MIRAGE
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
FDA Enforcement
Class II
·Terminated·Unimed Surgical Products, Inc.·September 5, 2012
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
FDA 510(k)
FDA Class 2
·Cardiovascular
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0360080·Compressor, Modular Tip
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106080·Trial, 26 x 8mm, 8 Degree, Tapered, Straight
Vario
FDA UDI
Ropox A/S·05707581000515·
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
.008" MIRAGE HYDROPHYLIC GUIDEWIRE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code DQX·March 25, 2014
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GEI·July 21, 2016
JAW INS.BIP.MACRO FORCEPS D: 5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG TUTTLINGEN 78532·Product code GEI·December 12, 2014
BIPOLAR MACRO FORCEPS D:5/ 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
JAW INS. BIP. MARYLAND DISS. FCPS 5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·January 14, 2015
REBAR
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 26, 2024
REBAR
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 26, 2024