20 results · 27ms · Sources: EU EUDAMED, 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