20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOS KING BIOCELLULOSE FILM
FDA 510(k)
FDA Unclassified
·Unknown
Mckesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479188242·GLOVE, EXAM POLYMER LTX PF MED
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018952·Kocher Fcps, cvd, 5 1/2" 1x2 th
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DPL NUVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·January 15, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·June 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·November 20, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·December 19, 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 8, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 22, 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·January 26, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·February 12, 2018
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code PNO·January 29, 2018
PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026