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

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JET BLUE BITE

FDA 510(k)
FDA Class 2 ·Dental

N/A

FDA UDI
GEORGE TIEMANN & CO.·B582B58210512430·HOLDER, NEEDLE, GASTROENTEROLOGIC

Dalbo®-S

FDA UDI
Cendres+Métaux SA·07640166513926·Dalbo®-S Male part C

SEMIAL 5°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844000755·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0112430·Awl Tap, 5.5 mm, Fixed Sleeve

DORNIER MEDILAS H

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

CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000

FDA 510(k)
FDA Class 2 ·Physical Medicine

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 19, 2024

UNKNOWN COPELAND SHOULDER

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

COPELAND SH HUM SZ4 STND PLUS

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

UNKNOWN COPELAND RESURFACING SHOULDER

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 10, 2013

CONCERTO II CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·April 12, 2011

PUMP MMT-515NAL PRDGM INS V2.1 CL EN

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 22, 2008

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

FDA Enforcement
Class II ·Ongoing·American Contract Systems Inc·September 3, 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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018