Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73393–73416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2003
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
K024338 · LYZ
General Gloves Corp.
General Hospital · 66d
Cleared Mar 03, 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · EKX
Aseptico, Inc.
Dental · 46d
Cleared Mar 03, 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 31d
Cleared Mar 03, 2003
TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1
K030380 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 26d
Cleared Mar 03, 2003
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
K030452 · JJY
Bayer Diagnostics Corp.
Chemistry · 20d
Cleared Mar 03, 2003
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · ETA
Invotec International, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 03, 2003
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING)...
K030524 · OBJ
Cd Leycom BV
Cardiovascular · 12d
Cleared Feb 28, 2003
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · FRN
Mettler Electronics Corp.
General Hospital · 164d
Cleared Feb 28, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · MRC
Ciba Vision Corporation
Ophthalmic · 136d
Cleared Feb 28, 2003
CATHETER CONNECTOR
K023690 · KNY
World Metals, Inc.
Gastroenterology & Urology · 119d
Cleared Feb 28, 2003
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
K023985 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 28, 2003
NYLON SUTURE
K024090 · GAR
Aurolab
General & Plastic Surgery · 79d
Cleared Feb 28, 2003
SILK SUTURES
K024091 · GAP
Aurolab
General & Plastic Surgery · 79d
Cleared Feb 28, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
K030091 · LON
Bd Diagnostic Systems
Microbiology · 49d
Cleared Feb 27, 2003
STARTOX DRUG OF ABUSE SCREENING TEST (4)
K022388 · DJC
Starplex Scientific, Inc.
Toxicology · 219d
Cleared Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 171d
Cleared Feb 27, 2003
DISPOSABLE BI-POLAR CABLE
K023966 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 27, 2003
AUTOMED 3200 INFUSION PUMP
K023973 · FRN
Help Technologies
General Hospital · 87d
Cleared Feb 27, 2003
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
K024050 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 80d
Cleared Feb 27, 2003
ALIBI BIOLOGICAL INDICATOR, MODEL WS
K024079 · FRC
Arden Laboratories, Incorporated
General Hospital · 79d
Cleared Feb 27, 2003
TOP GLOVE VINYL EXAMINATION GLOVE
K024216 · LYZ
Top Glove (Zhangjiagang) Co. , Ltd.
General Hospital · 66d
Cleared Feb 27, 2003
0.55% ORTH-PHTHALALDEHYDE SOLUTION
K030004 · MED
Advanced Sterilization Products
General Hospital · 56d
Cleared Feb 27, 2003
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50...
K030112 · LYY
Pt. Smartglove Indonesia
General Hospital · 45d
Cleared Feb 27, 2003
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
K030315 · KNS
Ultroid, LLC
Gastroenterology & Urology · 28d