ClearanceBrief
Company

MEDLINE INDUSTRIES, LP - Northfield

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
812recalls (0 in 12 months)
72recalls that name a 510(k)

Product codes

CodeDeviceRecords
LROGeneral Surgery Tray83
OJHOrthopedic Tray37
OEZCardiovascular Procedure Kit34
FDELaparoscopy Kit23
LRPTray, Surgical22
OESCardiac Catheterization Kit20
OJKEye Tray20
OGREar, Nose, And Throat Surgical Tray19
OFFCentral Venous Catheter Tray17
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)17
OJGNeurological Tray17
FTNPlastic Surgery And Accessories Kit16
MLSLabor And Delivery Kit16
OFGCt Biopsy Tray14
OHDGynecological Laparoscopic Kit14
KDDKit, Surgical Instrument, Disposable13
LRSI.V. Start Kit13
OFTSpinal Epidural Anesthesia Kit13
OXQDressing Change Tray13
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)12

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 19, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRA
Open, Classified
LRONone listed
Sep 19, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INT
Open, Classified
CAINone listed
Aug 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG
Open, Classified
FDENone listed
Aug 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH,
Open, Classified
NLHK241156
Aug 27, 2025MEDLINE INDUSTRIES, LP - Northfield
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of compo
Open, Classified
LROK213481
Jul 30, 2025MEDLINE INDUSTRIES, LP - Northfield
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Open, Classified
QBPK130975
Jul 21, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Open, Classified
OHMNone listed
Jul 21, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE,
Open, Classified
OIBNone listed
Jul 21, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
Open, Classified
LRSNone listed
Jul 21, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Open, Classified
LRONone listed
Jun 30, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Open, Classified
OJKNone listed
Jun 30, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Open, Classified
LRSNone listed
Jun 30, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PE
Open, Classified
LRONone listed
Jun 20, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Open, Classified
LRONone listed
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B D
Open, Classified
OJHNone listed
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Open, Classified
OJGK213481
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYN
Open, Classified
LROK213481
May 15, 2025MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Open, Classified
KDCNone listed
May 15, 2025MEDLINE INDUSTRIES, LP - Northfield
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Open, Classified
GADNone listed
May 2, 2025MEDLINE INDUSTRIES, LP - Northfield
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Open, Classified
MHIK983399
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Open, Classified
OJHNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Open, Classified
OJKNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Open, Classified
NSBNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
Open, Classified
MCYNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Open, Classified
LRPNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC318
Open, Classified
LRONone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Open, Classified
FDENone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Open, Classified
OGRNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Open, Classified
FRONone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295
Open, Classified
FROK173276
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number:
Open, Classified
OIINone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Refer to RES
Open, Classified
OJHNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK
Open, Classified
OJKNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB P
Open, Classified
OKVNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: D
Open, Classified
OJFNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M;
Open, Classified
OHMNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ646
Open, Classified
OHDNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Open, Classified
MLTNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number:
Open, Classified
MLSNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629
Open, Classified
OJGNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Open, Classified
PADNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
Open, Classified
KKXNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
Open, Classified
FQMNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Open, Classified
OJUNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Open, Classified
MDMNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
Open, Classified
LRSNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
Open, Classified
LRPNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Refer to RES
Open, Classified
LRONone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
Open, Classified
KDDNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ3416
Open, Classified
FTNNone listed

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