18 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

UP - Vehicle - 380-55230 - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)

RR - UP - Commuter Passenger - zlb

FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb

BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RIST Radial Access Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARE STIM

FDA 510(k)
FDA Class 2 ·Neurology

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022

JOSTENT GRAFTMASTER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 17, 2008

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 4, 2011

UNKNOWN DEPUY BONE CEMENT

FDA Adverse Event
Injury ·9610921 DEPUY CMW·Product code LOD·July 2, 2013

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 27, 2023

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 26, 2024

Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

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