FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83905–83928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
K993954 · DKB
Beckman Coulter, Inc.
Toxicology · 50d
Cleared Jan 11, 2000
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B...
K993971 · LLL
Micro Detect, Inc.
Immunology · 49d
Cleared Jan 11, 2000
FUJI II LC CAPSULE
K993973 · EBF
GC America, Inc.
Dental · 49d
Cleared Jan 11, 2000
MDI SM TEST
K994029 · LLL
Micro Detect, Inc.
Immunology · 46d
Cleared Jan 11, 2000
THE 4.5MM DIAMETER BICON DENTAL IMPLANT
K994037 · DZE
Bicon, Inc.
Dental · 43d
Cleared Jan 11, 2000
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
K994043 · LYY
Biopro (M) Sdn Bhd
General Hospital · 43d
Cleared Jan 10, 2000
PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
K991391 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 264d
Cleared Jan 10, 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962 · JDR
Groupe Lepine
Orthopedic · 214d
Cleared Jan 10, 2000
AMUKIN D
K992016 · LIF
Amuchina Intl., Inc.
Gastroenterology & Urology · 209d
Cleared Jan 10, 2000
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · FLE
Midmark Corp.
General Hospital · 147d
Cleared Jan 10, 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767 · JOJ
Albert Browne , Ltd.
General Hospital · 146d
Cleared Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859 · CHL
Radiometer America, Inc.
Chemistry · 138d
Cleared Jan 10, 2000
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · HKY
Automated Ophthalmics, Inc.
Ophthalmic · 125d
Cleared Jan 10, 2000
RADID DRUG SCREEN 5-PANEL TEST
K993151 · DJG
American Bio Medica Corp.
Toxicology · 111d
Cleared Jan 10, 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL...
K993411 · HIR
Mega Electronics , Ltd.
Gastroenterology & Urology · 90d
Cleared Jan 10, 2000
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
K993522 · JAI
Aktina Medical Physics Corp.
Radiology · 84d
Cleared Jan 10, 2000
FRIALIT-2 BONE PROFILER
K993560 · DZE
Friadent GmbH
Dental · 81d
Cleared Jan 10, 2000
MDI SM/RNP TEST
K993635 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 10, 2000
MDI SS-A TEST
K993636 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 10, 2000
CLINICAL BLOOD GAS MIXTURE
K993789 · CHL
General Air Service and Supply
Chemistry · 62d
Cleared Jan 10, 2000
CERGOGOLD
K993897 · EIH
Degussa - Ney Dental, Inc.
Dental · 55d
Cleared Jan 10, 2000
HARDYDISK DOXYCYCLINE, 30MCG
K994051 · JTN
Hardy Diagnostics
Microbiology · 41d
Cleared Jan 10, 2000
TITAN RC TACK
K994269 · MAI
Innovasive Devices, Inc.
Orthopedic · 21d
Cleared Jan 07, 2000
FLOSENSE, MODEL 29-8010
K990962 · JAX
Sdi Diagnostics, Inc.
Anesthesiology · 291d