FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87889–87912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847 · EIA
Germiphene Corp.
Dental · 32d
Cleared Dec 01, 1998
RITA MODEL 70 ELECTROSURGICAL PROBE
K983871 · GEI
Rita Medical Systems
General & Plastic Surgery · 29d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129 · GIZ
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · GGC
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · GGC
Pacific Hemostasis
Hematology · 13d
Cleared Nov 30, 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 178d
Cleared Nov 30, 1998
ROTECNO 2000 SURGICAL GOWN
K982059 · FYA
Encompass Group, LLC
General Hospital · 172d
Cleared Nov 30, 1998
FLUIDSENSE FLUID DELIVERY SYSTEM
K982170 · FRN
Fluidsense Corp.
General Hospital · 164d
Cleared Nov 30, 1998
NITRILE POWDER-FREE UNISEAL GLOVES
K982218 · LZA
American Healthcare Products (M) Sdn Bhd
General Hospital · 159d
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