18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 2.0 mm, cementable basic screw
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·XXXX50221079·BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 2.0 m...
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 2.0 mm, cementable basic screw
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50221071·BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 2.0 m...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496022107·NAOMI 140, SIZE XXL, SABBIA, GRADUATED COMPRESS...
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07901089809511·HO8-BASE(37-50) F/ DRILLS.-STANDER---BLACK
MedGyn Uterine Curette
FDA UDI
MEDGYN PRODUCTS, INC.·M803022107·Uterine Curette
Whistle Tip
FDA UDI
COOK INCORPORATED·00827002140325·Whistle Tip Ureteral Catheter (Right)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM
Pegasus
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215008864·
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
FDA 510(k)
FDA Unclassified
·Unknown
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
FDA 510(k)
FDA Class 2
·Immunology
24MM PRIMARY REAMER
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·January 7, 2025
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 10, 2011
CORTICAL BONE SCR 32MM
FDA Adverse Event
Malfunction
·DEPUY ACE S.A. 'R.L.'·Product code HSB·March 25, 2008
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018