446 results · 26ms · Sources: EU EUDAMED, US FDA

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Female Fertility Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PQO·November 3, 2025

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GET·February 14, 2023

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code MOQ·September 23, 2024

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GEY·February 15, 2023

PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

FDA Recall
Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

FDA Recall
Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

FDA Recall
Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code LNH·May 11, 2009

Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

FDA Recall
Terminated ·Product code GDO·October 31, 2001

Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

FDA Recall
Terminated ·General Electric Med Systems LLC·Product code IZH·November 16, 2005

GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201

FDA Recall
Terminated ·GE Healthcare Clinical Systems·Product code IYN·September 4, 2007

DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

FDA Recall
Terminated ·Diasorin Inc.·Product code LLM·March 14, 2007

Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".

FDA Recall
Terminated ·Pro Trainers' Choice Company·Product code ILO·April 18, 2011

Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.

FDA Recall
Terminated ·Horizon Medical Products Inc·Product code KOC·May 28, 2004

Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.

FDA Recall
Terminated ·Horizon Medical Products Inc·Product code KOC·May 28, 2004

Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·July 1, 2014

ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609

FDA Recall
Terminated ·Pfizer Global·Product code IMD·September 24, 2010