61 results · 13ms · 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.

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

FDA Recall
Open, Classified ·Biocare Medical, LLC·Product code PPM·September 25, 2024

Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

FDA Recall
Open, Classified ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code OMA·May 7, 2025

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code LTT·July 24, 2025

DAC 044 115cm, Catalog: 90760

FDA Recall
Open, Classified ·Stryker Neurovascular·Product code DQY·April 23, 2024

PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1

FDA Recall
Open, Classified ·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025

PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP

FDA Recall
Open, Classified ·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

FDA Recall
Open, Classified ·Raz Design Inc·Product code INN·January 5, 2026

Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KKX·April 8, 2024

18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;

FDA Recall
Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025