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
125977–126000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 11, 1990
SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX
K901321 · LDQ
Sharp Safe, Inc.
General & Plastic Surgery · 51d
Cleared May 11, 1990
KLEIN CORK(TM)
K901715 · GCE
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 28d
Cleared May 11, 1990
KLEIN CONNECTOR(TM)
K901716 · GCE
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 28d
Cleared May 10, 1990
ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG
K896314 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 190d
Cleared May 10, 1990
IONTOPHORESIS DEVICE - ELECTRODE RH 800
K896444 · EGJ
Iomed, Inc.
Physical Medicine · 182d
Cleared May 10, 1990
SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM
K897118 · LDP
Medisense, Inc.
Toxicology · 135d
Cleared May 10, 1990
OLYMPUS(TM) TOTAL BILIRUBIN
K897174 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 134d
Cleared May 10, 1990
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · DXS
Shiley, Inc.
Cardiovascular · 79d
Cleared May 10, 1990
SOFT-WEDGE(TM) SYRINGE
K900879 · DYG
Baxter Healthcare Corp
Cardiovascular · 73d
Cleared May 10, 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · CDQ
Technicon Instruments Corp.
Chemistry · 59d
Cleared May 10, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · CGJ
Medix Biotech, Inc.
Chemistry · 49d
Cleared May 10, 1990
MPR-4A - MICRO-PLATE READER
K901965 · JJQ
Tosoh Corp.
Chemistry · 10d
Cleared May 09, 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · DQA
Critikon Company, LLC
Anesthesiology · 334d
Cleared May 09, 1990
HTO COMPRESSING STAPLE
K895117 · JDR
Howmedica Corp.
Orthopedic · 267d