D & C Products Corp.

D & C PRODUCTS CORP.

FDA registration

D & C PRODUCTS CORP.·5 products·🇹🇼 Taiwan

SINGLE USE ELECTROSURGICAL KNIFE

FDA Adverse Event

Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·March 3, 2021

Single Use Electrosurgical Knife

FDA Adverse Event

Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·November 25, 2021

Single Use Electrosurgical Knife KD-650

FDA Adverse Event

Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·November 25, 2021

a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.

FDA Recall

Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRC·May 25, 2022

a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f. METREX RESEARCH CORP DISINFECTANT, ENVIROCIDE 24OZ(12/CS) METREX Model Number: 13-3324. g. METREX RESEARCH CORP Envirocide DISINFECTANT, ENVIROCIDE GL(4/CS)MX-3300 METREX Model Number: 13-3300

FDA Recall

Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LRJ·May 25, 2022

MedEnvoy Global BV

Authorized representative

🇳🇱 Netherlands·143 Manufacturers·2306 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

C-TAPER COCR LFIT HEAD 36MM/0

FDA Adverse Event

Malfunction ·STRYKER ORTHOPAEDICS·Product code JDI·February 5, 2010

DUODENOVIDEOSCOPE

FDA Adverse Event

Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·July 27, 2021

Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

FDA Enforcement

Class II ·Terminated·Applied Medical Resources Corp·July 17, 2019

EVIS LUCERA DUODENOVIDEOSCOPE

FDA Adverse Event

Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·October 29, 2021

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

FDA Enforcement

Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

TRIDENT 0 DEG CONSTRAINED INSERT 28F

FDA Adverse Event

Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWZ·February 6, 2015

Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

FDA Enforcement

Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM

FDA Adverse Event

Injury ·STRYKER GMBH (MDR)·Product code NTG·July 1, 2015

UNKNOWN_SELZACH_PRODUCT

FDA Adverse Event

Injury ·STRYKER GMBH (MDR)·Product code HRS·July 1, 2015

TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT

FDA Adverse Event

Malfunction ·STRYKER GMBH·Product code NTG·December 17, 2015

Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.

FDA Recall

Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·August 18, 2016