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
148201–148224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · GTZ
Armkel, LLC
Microbiology · 93d
Cleared May 29, 1985
TYPE FP30 DIGITAL HEARING AID ANALYZER
K850918 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 85d
Cleared May 29, 1985
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · GJS
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · GGW
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
K851127 · JPA
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared May 29, 1985
CHAMBER V-9 PLUS AGAR
K851238 · JSJ
Bug City Company, Inc.
Microbiology · 63d
Cleared May 29, 1985
LERE NAIL & PLATE COMBIN. ONE PIECE FORGED
K851349 · KTW
Medicalex
Orthopedic · 55d
Cleared May 29, 1985
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · ELW
Specialites Septodont
Dental · 50d
Cleared May 29, 1985
STERILE GENERAL HOSPITAL SUPPLIES
K851390 · LDQ
Biological & Environmental Control...
General & Plastic Surgery · 50d
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E35F
K851429 · ESD
Oticon Corp.
Ear, Nose, Throat · 49d
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E37F
K851430 · ESD
Oticon Corp.
Ear, Nose, Throat · 49d
Cleared May 29, 1985
BEHIND THE EAR HEARING AID MODEL BERNAFON T-82
K851547 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 43d
Cleared May 29, 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · EJH
Aalba Dent, Inc.
Dental · 42d
Cleared May 29, 1985
RAKA OCH BOSDA PEANGER
K851673 · GEN
General Electric Trading Co.
General & Plastic Surgery · 36d
Cleared May 29, 1985
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
K851746 · ERA
Artiberia
Ear, Nose, Throat · 34d
Cleared May 29, 1985
IMAX PERIOTIPS
K851841
Stram Dental, Inc.
Dental · 33d
Cleared May 29, 1985
UN(UREASE)REAGENT UN(A-KETO)REAGENT
K851991 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
GLU(GOD) REAGENT
K851992 · CGA
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
UA(URICASE) REAGENT
K852004 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
K852027 · DKJ
Advanced Biomedical Methods, Inc.
Toxicology · 21d
Cleared May 29, 1985
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES
K852035 · FRW
Continental Scale Corp.
General Hospital · 20d
Cleared May 28, 1985
ACCU-TRAC
K843055 · DXN
Olympic Medical Corp.
Cardiovascular · 298d
Cleared May 28, 1985
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO
K843580 · DRS
Graphic Controls Corp.
Cardiovascular · 259d
Cleared May 28, 1985
CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
K844116 · DXG
Critikon Company, LLC
Cardiovascular · 217d