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
| Code | Device | Records |
|---|---|---|
| LRO | General Surgery Tray | 83 |
| OJH | Orthopedic Tray | 37 |
| OEZ | Cardiovascular Procedure Kit | 34 |
| FDE | Laparoscopy Kit | 23 |
| LRP | Tray, Surgical | 22 |
| OES | Cardiac Catheterization Kit | 20 |
| OJK | Eye Tray | 20 |
| OGR | Ear, Nose, And Throat Surgical Tray | 19 |
| OFF | Central Venous Catheter Tray | 17 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 17 |
| OJG | Neurological Tray | 17 |
| FTN | Plastic Surgery And Accessories Kit | 16 |
| MLS | Labor And Delivery Kit | 16 |
| OFG | Ct Biopsy Tray | 14 |
| OHD | Gynecological Laparoscopic Kit | 14 |
| KDD | Kit, Surgical Instrument, Disposable | 13 |
| LRS | I.V. Start Kit | 13 |
| OFT | Spinal Epidural Anesthesia Kit | 13 |
| OXQ | Dressing Change Tray | 13 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 12 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | MEDLINE 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 |
LRO | None listed |
| Sep 19, 2025 | MEDLINE 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 |
CAI | None listed |
| Aug 28, 2025 | MEDLINE 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 |
FDE | None listed |
| Aug 28, 2025 | MEDLINE 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 |
NLH | K241156 |
| Aug 27, 2025 | MEDLINE 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 |
LRO | K213481 |
| Jul 30, 2025 | MEDLINE INDUSTRIES, LP - Northfield SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL
Model no. EMZE010301 Open, Classified |
QBP | K130975 |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
C-SECTION PREP, REF DYNJ32702B Open, Classified |
OHM | None listed |
| Jul 21, 2025 | MEDLINE 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 |
OIB | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
IV START KIT LAB DRAW-SH, REF CDS860014P Open, Classified |
LRS | None listed |
| Jul 21, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
LABOR TRIAGE KIT, REF DYKM1564 Open, Classified |
LRO | None listed |
| Jun 30, 2025 | MEDLINE 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 |
OJK | None listed |
| Jun 30, 2025 | MEDLINE 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 |
LRS | None listed |
| Jun 30, 2025 | MEDLINE 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 |
LRO | None listed |
| Jun 20, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 Open, Classified |
LRO | None listed |
| May 31, 2025 | MEDLINE 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 |
OJH | None listed |
| May 31, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits containing Codman Disposable Perforator 14 mm:
CRANIOTOMY, SKU DYNJ35349C Open, Classified |
OJG | K213481 |
| May 31, 2025 | MEDLINE 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 |
LRO | K213481 |
| May 15, 2025 | MEDLINE INDUSTRIES, LP - Northfield Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 Open, Classified |
KDC | None listed |
| May 15, 2025 | MEDLINE INDUSTRIES, LP - Northfield Centurion Sterile Weitlaner Retractor, Reorder: 67315 Open, Classified |
GAD | None listed |
| May 2, 2025 | MEDLINE INDUSTRIES, LP - Northfield Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 Open, Classified |
MHI | K983399 |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: HAND, REF DYNJ902002J Open, Classified |
OJH | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K Open, Classified |
OJK | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A Open, Classified |
NSB | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as:
1) WOUND CARE TRAY, REF DYNDA1412A;
2) LACERATION TRAY, REF DYNDL1263A. Open, Classified |
MCY | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 Open, Classified |
LRP | None listed |
| May 1, 2025 | MEDLINE 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 |
LRO | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 Open, Classified |
FDE | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 Open, Classified |
OGR | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 Open, Classified |
FRO | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile Water, USP, 100mL, REF RDI30295 Open, Classified |
FRO | K173276 |
| Apr 17, 2025 | MEDLINE 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 |
OII | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES Open, Classified |
OJH | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OJK | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OKV | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OJF | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OHM | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OHD | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) CW PERI GYN, Model Number: DYNJ80807B Open, Classified |
MLT | None listed |
| Apr 17, 2025 | MEDLINE 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 |
MLS | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OJG | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C Open, Classified |
PAD | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239 Open, Classified |
KKX | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339 Open, Classified |
FQM | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) SKIN LESION SET, Model Number: MNS6270 Open, Classified |
OJU | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) NAIL PACK, Model Number: SUT15830A; Open, Classified |
MDM | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) IV PACK SOUTH, Model Number: DYNJ88422 Open, Classified |
LRS | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) PRECIP TRAY, Model Number: MNS12590 Open, Classified |
LRP | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES Open, Classified |
LRO | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) MINOR BASIN -SMH, Model Number: DYNJ907733B Open, Classified |
KDD | None listed |
| Apr 17, 2025 | MEDLINE 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 |
FTN | None listed |
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