Medical Device Manufacturer · US , Raleigh , NC

Trinity Laboratories, Inc.

44 submissions · 28 cleared · Since 1990
44
Total
28
Cleared
0
Denied

Trinity Laboratories, Inc. — FDA 510(k) Submissions

Trinity Laboratories, Inc. has submitted 44 FDA 510(k) premarket notifications since 1990, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Drape, Surgical, Catheters, Suction, Tracheobronchial, Suture Removal Kit, Tube, Tracheostomy (w/wo Connector), General Surgery Tray . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · DQO Catheter, Intravascular,... · Cardiovascular
Jul 1998 80d
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · EIA Unit, Operative Dental · Dental
Feb 1998 84d
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · HFX Clamp, Circumcision · Obstetrics & Gynecology
Dec 1997 28d
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160 · DCK C-reactive Protein,... · Immunology
Aug 1997 53d
EYE TRAY
K970722 · KKX Drape, Surgical · General Hospital
Mar 1997 32d
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K965201 · LRO General Surgery Tray · General & Plastic Surgery
Feb 1997 50d
BASIC BIOPSY TRAY. DISPOSABLE, STERILE
K964921 · LRO General Surgery Tray · General & Plastic Surgery
Jan 1997 44d
MID-STREAM COLLECTION SET-STERILE
K953929 · LIO Device, Specimen Collection · Microbiology
Nov 1995 87d
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058 · FOZ Catheter, Intravascular,... · General Hospital
Sep 1995 142d
WOUNDFOAM 4 X 4
K953070 · KMF Bandage, Liquid · General & Plastic Surgery
Sep 1995 70d
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · BSY Catheters, Suction,... · Anesthesiology
Jul 1995 91d
STANDARD FOLEY SYSTEM PAK
K951443 · FCN Urinary Drainage... · Gastroenterology & Urology
Jun 1995 78d
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · FCM Tray, Catheterization,... · Gastroenterology & Urology
Jun 1995 77d
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K945671 · CAZ Anesthesia Conduction Kit · Anesthesiology
Feb 1995 90d
IRRIGATION TRAY WITH PISTON SYRINGE
K942221 · FMF Syringe, Piston · General Hospital
Aug 1994 91d
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · KMF Bandage, Liquid · General & Plastic Surgery
Jun 1994 65d
STERILE WATER WET DRESSING
K942014 · MGF · General & Plastic Surgery
May 1994 31d
STERILE WATER
K933526 · JOL Catheter And Tip, Suction · General Hospital
Mar 1994 232d
CRYPTO-LEX SYSTEM
K930418 · GMD Antisera, Latex... · Microbiology
Feb 1994 387d
YANKAUER WITH CONNECTING TUBING
K934750 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 1994 136d
SALINE WET DRESSING- STERILE
K934258 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Nov 1993 85d
SALINE SOLUTION-STERILE
K933412 · JOH Tube Tracheostomy And... · Anesthesiology
Oct 1993 80d
STAPH-A-LEX(TM) SYSTEM
K926173 · JWX Kit, Screening,... · Microbiology
Aug 1993 245d
I.V. START KIT, STERILE, DISPOSABLE
K923361 · LRS I.v. Start Kit · General & Plastic Surgery
Jun 1993 355d
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · KKX Drape, Surgical · General Hospital
Mar 1993 401d
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