FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87385–87408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1998
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
K982241 · CAC
Duxbury Scientific, Inc.
Anesthesiology · 158d
Cleared Nov 30, 1998
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · LYY
Ansell Perry
General Hospital · 138d
Cleared Nov 30, 1998
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
K982716 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 118d
Cleared Nov 30, 1998
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
K982797 · DYB
Luther Medical Products, Inc.
Cardiovascular · 112d
Cleared Nov 30, 1998
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
K982877 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 108d
Cleared Nov 30, 1998
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
K982898 · MOB
Immco Diagnostics, Inc.
Immunology · 105d
Cleared Nov 30, 1998
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K983172 · LCP
Diabetes Technologies, Inc. (Dti)
Hematology · 81d
Cleared Nov 30, 1998
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
K983240 · KGO
Johnson & Johnson Medical, Div. of...
General Hospital · 76d
Cleared Nov 30, 1998
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
K983244 · JTW
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Nov 30, 1998
TERUMO VENOJECT,LUER ADAPTER
K983490 · JKA
Terumo Corp.
Chemistry · 56d
Cleared Nov 30, 1998
KLS INTRAORAL VERTICAL DISTRACTOR
K983515 · MQN
KLS-Martin L.P.
Dental · 54d
Cleared Nov 30, 1998
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983531 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 53d
Cleared Nov 30, 1998
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983532 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 53d
Cleared Nov 30, 1998
MODIFICATION OF PQ1
K983668 · KLE
Ultradent Products, Inc.
Dental · 42d
Cleared Nov 30, 1998
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
K983750 · FMI
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Nov 30, 1998
QUADRANT UNICHEM
K983751 · EBF
Cavex Holland BV
Dental · 38d
Cleared Nov 30, 1998
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K983869 · LRJ
Caltech Industries, Inc.
General Hospital · 28d
Cleared Nov 30, 1998
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K983975 · FRN
Belmont Instrument Corp.
General Hospital · 21d
Cleared Nov 30, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN...
K984034 · MOB
Zeus Scientific, Inc.
Immunology · 18d
Cleared Nov 27, 1998
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
K983066 · ITI
Teftec Corp.
Physical Medicine · 86d
Cleared Nov 27, 1998
SUTURE WELDING SYSTEM AND KIT (SWK)
K983108 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 84d
Cleared Nov 27, 1998
DOMINATOR
K983681 · IOR
Impact Wheelchair Manufacture, Inc.
Physical Medicine · 38d
Cleared Nov 25, 1998
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
K981365 · MSD
Sherwood Medical Co.
Gastroenterology & Urology · 224d
Cleared Nov 25, 1998
AB FLU OIA
K981651 · PSZ
Biostar, Inc.
Microbiology · 198d