FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126553–126576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1990
ASO-CUBE(TM)
K901371 · GTQ
Difco Laboratories, Inc.
Microbiology · 53d
Cleared May 15, 1990
CONCEPT INLAY/ONLAY
K901396 · EBF
Ivoclar North America, Inc.
Dental · 50d
Cleared May 15, 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
K901450 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 48d
Cleared May 15, 1990
LYNX-SM, SCLAER DENTAL HANDPIECE
K901488 · ELC
Mti Precision Products
Dental · 47d
Cleared May 15, 1990
UMBILICAL CORD CLAMP AND CUTTER
K901557 · HFW
Microtek-Heritage, Inc.
Obstetrics & Gynecology · 42d
Cleared May 15, 1990
ESCORT-LINK (MODEL E3200)
K901591 · DXH
Medical Data Electronics
Cardiovascular · 40d
Cleared May 15, 1990
TROBICIN SUSCEPTIBILITY POWDER
K902004 · LOP
The Upjohn Co.
Microbiology · 39d
Cleared May 14, 1990
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
K894911 · GXZ
Dantec Electronics, Inc.
Neurology · 286d
Cleared May 14, 1990
AP201 DENTAL X-RAY FILM PROCESSOR
K900156 · EGY
Allied Photo Products Co., Inc.
Radiology · 122d
Cleared May 14, 1990
DRESSING CHANGE KIT
K900665 · FXX
Healthdyne Cardiovascular, Inc.
General Hospital · 90d
Cleared May 14, 1990
MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
K900919 · LNH
Summit World Trade Corp.
Radiology · 83d
Cleared May 14, 1990
CHEM I CLINICAL ANALYZER URINE MAGNESIUM
K901124 · JGJ
Technicon Instruments Corp.
Chemistry · 63d
Cleared May 14, 1990
HYCOR ACCUPINCH THC TEST
K901334 · LDJ
Hycor Biomedical, Inc.
Toxicology · 53d
Cleared May 14, 1990
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455 · HSZ
Kirschner Medical Corp.
Orthopedic · 42d
Cleared May 14, 1990
WAKO(TM) AUTOKIT URIC ACID
K901544 · KNK
Wako Chemicals USA, Inc.
Chemistry · 41d
Cleared May 14, 1990
MODEL 4050-64
K901639 · LNH
Medical Advances, Inc.
Radiology · 35d
Cleared May 11, 1990
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
K900697 · LLZ
Nuccardiac Software, Inc.
Radiology · 87d
Cleared May 11, 1990
HERPTRAN CONCENTRATE
K900713 · LGC
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 86d
Cleared May 11, 1990
SPECIMEX DC
K900740 · GXZ
Soredex Medical Systems
Radiology · 84d
Cleared May 11, 1990
DIGITAL IMAGE ENHANCEMENT SYSTEM
K900851 · LLZ
Atomic Products Corp.
Radiology · 78d
Cleared May 11, 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
K900904 · FGE
Candela Laser Corp.
Gastroenterology & Urology · 73d
Cleared May 11, 1990
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · JSP
Vitek Systems, Inc.
Microbiology · 70d
Cleared May 11, 1990
TESTPACK PLUS STREP A
K901274 · GTZ
Abbott Laboratories
Microbiology · 53d
Cleared May 11, 1990
DISPOSIBLE EEG NEEDLE ELECTRODES
K901280 · GXZ
Medicotest, Inc.
Neurology · 53d