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
137785–137808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1987
PERFECT SUNTANNING BED
K873589 · LEJ
Wolff System Technology Corp.
General & Plastic Surgery · 55d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1987
EMIT QST GENTAMICIN ASSAY
K873855 · LCD
Syva Co.
Toxicology · 37d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA OPIATE ASSAYS
K873898 · DJG
Syva Co.
Toxicology · 35d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 29, 1987
MULTICHEM ALBUMIN REAGENT S0902
K874049 · CIX
Simmler, Inc.
Chemistry · 24d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA AMPHETAMINE ASSAY
K874080 · DKZ
Syva Co.
Toxicology · 23d
Cleared Oct 29, 1987
AHH NATURAL BREAST FORM
K874279 · GBI
Pacific Prosthetics, Inc.
General & Plastic Surgery · 9d
Cleared Oct 28, 1987
MODEL SKCK STERILE KNOB COVER KIT
K870662 · BXM
Life-Tech Intl., Inc.
Anesthesiology · 251d
Cleared Oct 28, 1987
C.L.E. ACETABULAR CUP
K870922 · JDI
Protek, Inc.
Orthopedic · 239d
Cleared Oct 28, 1987
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS
K871878 · LSK
Gen-Probe, Inc.
Microbiology · 167d
Cleared Oct 28, 1987
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · JJF
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Oct 28, 1987
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
K872379 · JWH
Zimmer, Inc.
Orthopedic · 131d
Cleared Oct 28, 1987
MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT
K872986 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 89d
Cleared Oct 28, 1987
ENTERIC ISOLATION MEDIA
K873261 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
DIFFERENTIAL MEDIA
K873262 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA
K873263 · JSH
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS
K873264 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION
K873265 · JSI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
MIDDLEBROOK BASED MEDIA
K873266 · KZI
Central Media
Microbiology · 78d
Cleared Oct 28, 1987
CARBAMAZEPINE (FPIA) CALIBRATOR KIT
K873281 · DLJ
Windsor Laboratories, Inc.
Toxicology · 72d
Cleared Oct 28, 1987
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377 · GBS
Gish Biomedical, Inc.
General & Plastic Surgery · 65d
Cleared Oct 28, 1987
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · MBV
Protek, Inc.
Orthopedic · 64d
Cleared Oct 28, 1987
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
K873459 · KTT
Howmedica Corp.
Orthopedic · 61d