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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126577–126600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1990
BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
K901129 · BSO
Medevice, Inc.
Anesthesiology · 18d
Cleared Mar 30, 1990
PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
K901295 · IOQ
The Medical Group, Inc.
Physical Medicine · 10d
Cleared Mar 29, 1990
BARD/ANGIOMED STENTS
K896391 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 143d
Cleared Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · CGA
Heraeus Kulzer, Inc.
Chemistry · 100d
Cleared Mar 29, 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · KLI
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 97d
Cleared Mar 29, 1990
COULTER CHOLESTEROL REAGENT
K897162 · CHH
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Mar 29, 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · KLS
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 86d
Cleared Mar 29, 1990
PERCU-SET(TM)
K900021 · HIO
E-Z-Em, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 29, 1990
FREE T4 IMMUNOASSAY KIT
K900060 · CEC
Advanced Magnetics, Inc.
Chemistry · 85d
Cleared Mar 29, 1990
EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS
K900680 · HRX
Effner, Inc.
Orthopedic · 45d
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · JHI
Bd Becton Dickinson Vacutainer...
Toxicology · 23d
Cleared Mar 29, 1990
ELITECH GAMMA GT TEST KIT
K901090 · JPZ
Elite Technology, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
K901113 · JIS
Verichem Laboratories, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122 · CFR
Technicon Instruments Corp.
Chemistry · 17d
Cleared Mar 29, 1990
COULTER MAGNESIUM REAGENT
K901265 · JGJ
Coulter Corp.
Chemistry · 13d
Cleared Mar 28, 1990
POLYSTAN HEART-LUNG MACHINE SYSTEM
K894657 · DJQ
Polystan C/O Vitalcor, Inc.
Toxicology · 247d
Cleared Mar 28, 1990
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · DQR
Shiley, Inc.
Cardiovascular · 247d
Cleared Mar 28, 1990
OSSEODENT(R) PRECISION DENTAL ATTACHMENTS
K895463 · DZE
Collagen Corp.
Dental · 203d
Cleared Mar 28, 1990
OXYMAX
K895791 · BZL
Columbus Instruments Intl. Corp.
Anesthesiology · 181d
Cleared Mar 28, 1990
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
K896118 · HET
American Surgical Instruments Corp.
Obstetrics & Gynecology · 156d
Cleared Mar 28, 1990
PLAK TRAC POWERED TOOTHBRUSH
K896245 · JEQ
Windmere Corp.
Dental · 149d
Cleared Mar 28, 1990
CORDIS SHUTTLE CATHETER
K896308 · DQO
Cordis Corp.
Cardiovascular · 147d
Cleared Mar 28, 1990
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · LZU
Look, Inc.
Ophthalmic · 90d