44 results · 14ms · Sources: EU EUDAMED, US FDA

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Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JWH·August 9, 2016

Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·June 10, 2013

Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

FDA Recall
Terminated ·Express Diagnostics Int'l., Inc.·Product code JXN·October 4, 2010

life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

FDA Recall
Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

FDA Recall
Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

FDA Recall
Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300

FDA Recall
Terminated ·Medtronic Xomed, Inc.·Product code ERL·December 15, 2021

Foot Control, SC2100 Product Usage: Electric system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·March 28, 2016

Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

FDA Recall
Terminated ·Medtronic Xomed, Inc.·Product code ERL·June 12, 2020

Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpose 80 count; 4. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 80 count; 5. Medline non-sterile Cotton Rounds 80 count; 6. Simply Soft Cotton Rounds - Trial Size 30 counts; 7. Simply Soft Premium Cotton Rounds 80 Count; and 8. W Textured Cotton Rounds 240 Count. For application of cleansers and astringents, and the removal of makeup and nail polish; for cleaning superficial cuts and scrapes and applying medication to the skin.

FDA Recall
Terminated ·Medline Industries Inc·Product code FRL·May 25, 2021

Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·May 6, 2013

Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

FDA Recall
Terminated ·American Surgical Company·Product code FRL·March 31, 2016