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
128593–128616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1989
L.T.C. 1000 URINARY DRAINAGE BAG
K895957 · KNX
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 13d
Cleared Oct 24, 1989
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
K895994 · LJM
Lipogen, Inc.
Immunology · 11d
Cleared Oct 23, 1989
GLYCABEN
K893453 · LCP
Exocell, Inc.
Chemistry · 173d
Cleared Oct 23, 1989
MICRO-PLATE READER, MDX-1
K894400 · JJX
Medix Biotech, Inc.
Chemistry · 96d
Cleared Oct 23, 1989
BT-338N ELECTRONIC CLINICAL THERMOMETER
K894627 · FCI
Integrated Display Technology, Ltd.
Gastroenterology & Urology · 91d
Cleared Oct 23, 1989
RS232 FLOW SENSOR AND SOFTWARE PACKAGE
K894680 · BZG
Tamarac Systems Corp.
Anesthesiology · 90d
Cleared Oct 23, 1989
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · CGR
Diagnostic Products Corp.
Chemistry · 76d
Cleared Oct 23, 1989
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Oct 23, 1989
GAUZE SPONGE
K895086 · EFQ
Keilei Intl., Inc.
General & Plastic Surgery · 76d
Cleared Oct 23, 1989
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · CGJ
Bd Becton Dickinson Vacutainer...
Chemistry · 69d
Cleared Oct 23, 1989
HI CHEM CALIBRATOR A+
K895135 · JIX
Hichem Diagnostics
Chemistry · 68d
Cleared Oct 23, 1989
FORTRESS 1000FS ADD-ON POWER UNIT
K895596 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 38d
Cleared Oct 23, 1989
URIC ACID PAP
K895665 · KNK
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 20, 1989
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 507d
Cleared Oct 20, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891301 · LYY
Taiping Leasing Corp. Sdn. Bhd.
General Hospital · 221d
Cleared Oct 20, 1989
SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH
K891458 · IPF
Back IN Action, Inc.
Physical Medicine · 219d
Cleared Oct 20, 1989
IMPLA-MED IMPLANT SYSTEM
K892124 · DZE
Impla-Med
Dental · 199d
Cleared Oct 20, 1989
HEATED SERVO HUMIDIFIER, MODEL HDS 2
K893122 · BTT
Lifetronics, Inc.
Anesthesiology · 178d
Cleared Oct 20, 1989
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · DTZ
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 20, 1989
SKYROCK AND LIGHT SUPERBOND
K894639 · DYH
Dent Zar, Inc.
Dental · 88d
Cleared Oct 20, 1989
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
K894644 · EBF
Jeneric/Pentron, Inc.
Dental · 88d
Cleared Oct 20, 1989
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
K894658 · JWH
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 20, 1989
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · CAC
Shiley, Inc.
Anesthesiology · 87d
Cleared Oct 20, 1989
CYPRESS MEDICAL BONE SCREW & PLATES
K894719 · HWC
Cypress Medical Mfg., Inc.
Orthopedic · 88d