16 results · 27ms · Sources: EU EUDAMED, US FDA

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ULTICARE DISPOSABLE SYRINGES AND NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1

FDA 510(k)
FDA Class 2 ·Orthopedic

NEUROTOLOGY DRAPE, MODEL TBD

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SYRINGE 10ML LL S/C 200

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2020

NAIL HANDLE T2 TIBIA

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

TROCAR, LONG T2 FEMUR

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

RESTORE

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

TI CLICK'X LOCKING CAP FOR TI 3-D HEAD

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code NKB·April 12, 2011

PUMP MMT-512LNAL PRDGM INS CL EN US LN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·June 16, 2008

INFUSOMAT SPACE

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·March 3, 2016

NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018