19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUMED HAND FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018976·Kocher Fpcs, slim, cvd, 5 1/2" (13.5cm)
Mckesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479188266·GLOVE, EXAM POLYMER LTX PF LG
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZIRPRIME
FDA 510(k)
FDA Class 2
·Dental
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·February 18, 2019
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code DQO·January 17, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
LACTOSORB 2.0X5MM SUSPENSION PUSH SCREW, 2PK
FDA Adverse Event
Other
·BIOMET MICROFIXATION·Product code MAI·August 19, 2008
ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 20, 2022
ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 36-41 WIDE X 5.5 MM ROD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 21, 2022
ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 21, 2022
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 17, 2019
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 14, 2019
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·July 11, 2019
PKG, GRASPER FORCEPS, ATRAUMATIC, P/N 0250080323. 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