15 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.

Puritan Bennett Cuff Pressure Manager

FDA 510(k)
FDA Class 2 ·Anesthesiology

NA

FDA UDI
Synthes GmbH·10886982145062·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM

SAFESTEP 22GX3/4

FDA Adverse Event
Injury ·C.R. BARD INC. (BASD)·Product code FPA·January 16, 2009

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

WELL-TENS

FDA 510(k)
FDA Class 2 ·Neurology

SAFESTEP 22G X 3/4

FDA Adverse Event
Malfunction ·C. R. BARD INC. (BASD)·Product code FPA·February 6, 2009

SAFESTEP 22GX3/4

FDA Adverse Event
Malfunction ·C. R. BARD INC. (BASD)·Product code FPA·February 6, 2009

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

SAIPH KNEE

FDA Adverse Event
Malfunction ·MATORTHO·Product code JWH·October 9, 2018

PERCLOSE A-T SUTURE MEDICATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013

Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. 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