47 results · 21ms · 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.

U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.

FDA Recall
Terminated ·Milabs Bv Heidelberglaan·Product code RFK·April 15, 2012

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia

FDA Recall
Terminated ·Epimed International, Inc.·Product code BSP·April 22, 2016

MicroAire K-Wires

FDA Recall
Terminated ·MicroAire Surgical Instruments, LLC·Product code HTY·February 21, 2017

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025

King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

FDA Recall
Terminated ·King Systems Corp.·Product code CAE·December 13, 0012

Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

FDA Recall
Terminated ·Wright Medical Technology, Inc.·Product code LRO·July 28, 2020

Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

FDA Recall
Terminated ·Wright Medical Technology, Inc.·Product code LRO·July 28, 2020

KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432

FDA Recall
Open, Classified ·King Systems Corp. dba Ambu, Inc.·Product code CAE·September 26, 2024

Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJF·November 17, 2022

Bed/chair alarm

FDA Recall
Terminated ·RF Technologies, Inc.·Product code KMI·December 16, 2002

Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

FDA Recall
Terminated ·RF Technologies, Inc.·Product code KMI·May 17, 2013