57 results · 20ms · 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.

BD Vacutainer Specimen Collection Cups, Cat. No. 364975

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

BD Vacutainer Urine Collection Cups, Cat. No. 364941

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code FMF·October 20, 2017

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code GCP·April 19, 2017

A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code GCP·August 18, 2017

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code GCP·November 11, 2025

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code GCP·September 13, 2024

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code GCP·September 13, 2024

MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

FDA Recall
Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code PFT·April 26, 2018

Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

FDA Recall
Terminated ·C P Medical, Inc.·Product code NEW·September 22, 2014

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

LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

FDA Recall
Terminated ·GMP Companies/Lifesync Corporation·Product code DRG·January 10, 2007

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

FDA Recall
Open, Classified ·CP Medical Inc·Product code GAM·February 2, 2017

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

FDA Recall
Open, Classified ·CP Medical Inc·Product code GAM·October 18, 2019

Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'. Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' . Product was distributed to single consignee, a distributor in South Africa.

FDA Recall
Terminated ·C P Medical·Product code GAT·April 3, 2007