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
72265–72288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2003
MIDMARK M9 ULTRACLAVE STEAM STERILIZER
K023348 · FLE
Midmark Corp.
General Hospital · 147d
Cleared Mar 03, 2003
MS PAED-BABY BODY
K023796 · CCM
Erich Jaeger GmbH
Anesthesiology · 110d
Cleared Mar 03, 2003
TENSCARE ULTIMA NMS/EMS
K023997 · IPF
Tenscare, Ltd.
Physical Medicine · 90d
Cleared Mar 03, 2003
XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
K024004 · DZE
Friadent GmbH
Dental · 89d
Cleared Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · CGA
Bayer Corp.
Chemistry · 84d
Cleared Mar 03, 2003
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K024182 · CDQ
Precision Systems, Inc.
Chemistry · 74d
Cleared Mar 03, 2003
PROMOTOR FINAL RINSE SPERM WASH MEDIUM
K024290 · MQL
Ceres Fertility, Inc.
Obstetrics & Gynecology · 70d
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