21 results · 23ms · Sources: EU EUDAMED, US FDA

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GAMMA3 NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091034002·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

NIFometer

FDA UDI
MERCURY ENTERPRISES, INC.·10641043340028·

4.0 X 30MM DRILL SLEEVE

FDA UDI
Osteocentric Technologies, Inc.·00816950029721·4.0 X 30MM DRILL SLEEVE

pjur Aqua

FDA UDI
Pjur Group Luxembourg SA·00827160110086·Water-based Personal Lubricant

K034020

FDA Adverse Event
Injury ·C.R. BARD, INC. (BASD)·Product code LJS·November 16, 2007

N/A

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024367333·Heel Rest, 13 cm

TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

TRANSDUCER, S8 3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

TRANSDUCER S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·June 10, 2022

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 3, 2013

UNKNOWN DEPUY SIZE 2 RT POROUS COATED FEMUR

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 17, 2011

SJM EPIC STENTED TISSUE VALVE

FDA Adverse Event
Injury ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·April 25, 2008

PLUM LS PRIM. 225 CM CLAVE PORT DISTA

FDA Adverse Event
Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013

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