170 results · 23ms · 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.

PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

FDA Recall
Terminated ·Handicare Usa Inc·Product code FSA·September 8, 2017

Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

FDA Recall
Open, Classified ·Drs Vascular, Inc·Product code KGS·May 16, 2025

FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code KGS·March 24, 2006

TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code MQV·September 29, 2006

TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code MQV·September 29, 2006

Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

FDA Recall
Terminated ·Product code GAP·June 3, 2011

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

FDA Recall
Terminated ·Medtest Holdings, Inc.·Product code CGS·October 19, 2011

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code CGS·July 18, 2018

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·May 3, 2019

NAD Profile Test

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

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code CGS·July 18, 2018

Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·May 3, 2019

CK MB Calibrator, Catalogue Number CK2393

FDA Recall
Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CGS·March 25, 2022

Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030

FDA Recall
Terminated ·Abbott Laboratories Inc.·Product code CGS·October 12, 2007

InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.

FDA Recall
Terminated ·Stryker Endoscopy·Product code FGS·September 29, 2010

Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017

Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number: GL33MG and GLJ50M; POLYSORB 3/0 18" VIOLET V-20 DT, Item Number: GL63MG; POLYSORB 3/0 30" VIOLET V-20 DT, Item Number: GL67M; POLYSORB 3/0 60 U/D REEL 104R, Item Number: LL102; POLYSORB 3-0 30" VIOLET CV-25 DT, Item Number: GL182M; POLYSORB 4/0 18" VIOLET CV-25 DT, Item Number: GL34MG; POLYSORB 4/0 30" VIOLET V-20 DT, Item Number: GL68M; POLYSORB* 0 18" VIOLET GS-21 DT, Item Number: CL10MG; POLYSORB* 0 24" VIOLET PRECUT, Item Number: L34; POLYSORB* 0 30" VIOLET GS-21 REG ATTCH, Item Number: 3CL812; POLYSORB* 0 30" VIOLET GS-22 DT, Item Number: CL886M; POLYSORB* 0 30" VIOLET PRECUT, Item Number: L40; POLYSORB* 0 5 X 30" UNDYED GS-21 DT, Item Number: CL2M; POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH, Item Number: CL997MG; POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH, Item Number: CL71M; POLYSORB* 0 VIOLET 60 REEL, Item Number: LL114; POLYSORB* 0 VIOLET 98" REEL, Item Number: LL224; POLYSORB* 1 18" VIOLET PRE-CUT, Item Number: L35; POLYSORB* 1 30" VIOLET PRECUT, Item Number: L41; POLYSORB* 1 5 X 30" VIOLET HOS-12 DT, Item Number: CL97MG; POLYSORB* 1 VIOLET 30" GS-26, Item Number: CL60M; POLYSORB* 1 VIOLET 98" REEL, Item Number: LL225; POLYSORB* 2 30" VIOLET GS-25 DT, Item Number: CL665M; POLYSORB* 2 UNDYED 12X18" PRECUT, Item Number: L26; POLYSORB* 2 VIOLET 12X18" PRECUT, Item Number: L28; POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM), Item Number: 2CL852; POLYSORB* 2 VIOLET 30" GS-26, Item Number: CL659M; POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH*, Item Number: CL622M; POLYSORB* 2 VIOLET 6X30" PRE-CUT, Item Number: L42; POLYSORB* 2 VIOLET 98" REEL, Item Number: LL226; POLYSORB* 2-0 VIOLET 60 REEL, Item Number: LL113; POLYSORB* 2-0 VIOLET 98" REEL, Item Number: LL223; POLYSORB* 3-0 VIOLET 60 REEL, Item Number: LL112; POLYSORB* 3-0 VIOLET 98" REEL, Item Number: LL222; POLYSORB* 4/0 98" VIOLET REEL 110T, Item Number: LL221

FDA Recall
Terminated ·Medtronic·Product code GAM·May 3, 2017

CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

FDA Recall
Open, Classified ·GS Biomark LLC·Product code QJR·August 8, 2022

SICAT IMPLANT V2.0

FDA Recall
Terminated ·SICAT GMBH & CO. KG Brunnenallee·Product code LLZ·July 15, 2020