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
92665–92688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1997
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · IYE
Varian Medical Systems, Inc.
Radiology · 358d
Cleared Jul 22, 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · LDF
Medtronic Vascular
Cardiovascular · 298d
Cleared Jul 22, 1997
TOX A/B TEST
K971182 · LLH
Techlab, Inc.
Microbiology · 113d
Cleared Jul 22, 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · GJT
Precision Biologicals, Inc.
Hematology · 111d
Cleared Jul 22, 1997
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
K971437 · NYN
Murray Electronics
Neurology · 95d
Cleared Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · LJB
Inova Diagnostics, Inc.
Microbiology · 82d
Cleared Jul 22, 1997
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · CFR
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared Jul 22, 1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
K971761 · JJE
Biochem Immunosystems (U.S.), Inc.
Chemistry · 71d
Cleared Jul 22, 1997
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
K971797 · HET
Louisville Laboratories, Inc.
Obstetrics & Gynecology · 68d
Cleared Jul 22, 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT
K971801 · EZL
Louisville Laboratories, Inc.
Gastroenterology & Urology · 68d
Cleared Jul 22, 1997
OPUS ETHANOL
K972011 · DIC
Behring Diagnostics, Inc.
Toxicology · 53d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · LBS
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
K972404 · KJA
Bd Becton Dickinson Vacutainer...
Pathology · 26d
Cleared Jul 21, 1997
CPROTECTOR 2000
K960587 · CBP
Certified Safety Mfg., Inc.
Anesthesiology · 525d
Cleared Jul 21, 1997
UNI-GRAFT K DV
K963790 · DSY
Atrium Medical Corp.
Cardiovascular · 304d
Cleared Jul 21, 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · JAD
Victoreen, Inc.
Radiology · 223d
Cleared Jul 21, 1997
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
K970178 · KNT
Corpak, Inc.
Gastroenterology & Urology · 185d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573 · LNH
Toshiba America Mri, Inc.
Radiology · 157d
Cleared Jul 21, 1997
CHASE VESSEL CANNULA
K971019 · DWF
Chase Medical, Inc.
Cardiovascular · 123d
Cleared Jul 21, 1997
DINABASE (TM)
K971138 · EBI
Sultan Chemists, Inc.
Dental · 115d
Cleared Jul 21, 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · DYB
Cordis Corp.
Cardiovascular · 81d
Cleared Jul 21, 1997
ANTIBACTERIAL GUTTA PERCHA
K971641 · EKM
Dr. Howard Martin, P.A.
Dental · 80d
Cleared Jul 21, 1997
TIADAPT ABUTMENT SYSTEM
K971706 · NHA
Nobel Biocare Uas, Inc.
Dental · 74d
Cleared Jul 21, 1997
CAUTERIZATION SMOKE EVACUATOR
K971758 · GEI
Applied Medical Technologies
General & Plastic Surgery · 69d