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
168073–168096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · CGN
Abbott Laboratories
Chemistry · 18d
Cleared Nov 13, 1979
LIFELINE - ENDOCARDIAL PACING LEAD
K792168 · DTB
Intermedics, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
PERCUTANEOUS SHEATH (MULTI-CATH)SIDE
K792170 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
COMPLETE TRAY CENTRAL VENOUS PRESSURE
K792171 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
PERCUTANEOUS SHEATH INTRO. KIT OR TRAY
K792172 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · CDD
New England Nuclear
Chemistry · 15d
Cleared Nov 13, 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · JJS
Corning Medical & Scientific
Chemistry · 15d
Cleared Nov 13, 1979
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K792183 · LBS
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 15d
Cleared Nov 13, 1979
NORDICLAB TOTAL ESTRIOL RIA TEST
K792189 · CGI
Nordiclab Intl.
Chemistry · 13d
Cleared Nov 13, 1979
VITA-STAT MODEL 900A
K792192 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 12d
Cleared Nov 13, 1979
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
K792196 · JJR
Photovolt Corp.
Chemistry · 12d
Cleared Nov 07, 1979
ELA MEDICAL ANATEC HOLTER SCANNER
K792239
Ela Medical, Inc.
Cardiovascular
Cleared Nov 05, 1979
PROTEIN ASSAY KIT
K790808 · CEK
Specialty Medical Industries, Inc.
Chemistry · 193d
Cleared Nov 05, 1979
RIA KIT FOR TRYPSIN
K791202 · JNO
Cis Radiopharmaceuticals, Inc.
Chemistry · 130d
Cleared Nov 05, 1979
MINISPIROMETER SP-1
K791422 · BZG
Renesco International, Inc.
Anesthesiology · 112d
Cleared Nov 05, 1979
BLADDER RETENTION CATHETERIZATION TRAY
K791674 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 70d
Cleared Nov 05, 1979
AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP
K791720 · FRN
Alza Corp.
General Hospital · 67d
Cleared Nov 05, 1979
RIONET HEARING AID MODEL HA-55
K791739 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
(MICRO-KERATRON, MICRO DUCT TREPHINE)
K791763 · HRG
Intl. Ophthalmic Industries Corp.
Ophthalmic · 61d
Cleared Nov 05, 1979
MASTERSON* ENDOMETRIAL BIOPSY KIT
K791765 · HHK
Codman & Shurtleff, Inc.
Obstetrics & Gynecology · 69d
Cleared Nov 05, 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · DTB
Cordis Corp.
Cardiovascular · 61d
Cleared Nov 05, 1979
SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
K791812 · IXR
Spectrum X-Ray Corp.
Radiology · 48d
Cleared Nov 05, 1979
HOLLOW FIBER DIALIZER MODEL TRIEX-3
K791857
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 47d
Cleared Nov 05, 1979
ROYCO MODEL 921 CELL COUNTER
K791867 · GKL
Royco Instruments
Hematology · 45d