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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103129–103152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1995
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · JXN
Microgenics Corp.
Toxicology · 50d
Cleared May 02, 1995
IN-CERAM SPINELL
K951183 · EIH
Vident
Dental · 47d
Cleared May 02, 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K951360 · CHP
Bayer Corp.
Chemistry · 36d
Cleared May 02, 1995
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
K951435 · JJR
Aalto Scientific, Ltd.
Chemistry · 36d
Cleared May 02, 1995
TYTIN ADMIX
K951511 · EJJ
Kerr Corporation (Danbury)
Dental · 29d
Cleared May 02, 1995
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
K951638 · JHY
Organon Teknika Corp.
Chemistry · 22d
Cleared May 01, 1995
STC DIAGNOSTIC 8000
K935368 · IKN
Sherman Technology Corp.
Neurology · 543d
Cleared May 01, 1995
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · MEG
Smith & Nephew, Inc.
General Hospital · 497d
Cleared May 01, 1995
ELVIS HSV
K941924 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 376d
Cleared May 01, 1995
FINGERPRINT-DOA
K942836 · DKZ
Fingerprint Bioteck, Inc.
Toxicology · 320d
Cleared May 01, 1995
ACCUMETER HDL CHOLESTEROL TEST
K943279 · LBS
Chemtrak, Inc.
Chemistry · 298d
Cleared May 01, 1995
IL TEST PHENYTION CALIBRATORS
K943980 · DIP
Instrumentation Laboratory CO
Toxicology · 328d
Cleared May 01, 1995
MECHANICAL WHEELCHAIR- IMPACT
K945152 · IOR
Colours 'N Motion
Physical Medicine · 193d
Cleared May 01, 1995
MICRO-ENDO(TM) INSTRUMENTS
K950130 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 109d
Cleared May 01, 1995
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
K951393 · HEM
Solomon Technology Labs
Obstetrics & Gynecology · 35d
Cleared May 01, 1995
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · BSP
Sherwood Medical Co.
Anesthesiology · 34d
Cleared Apr 28, 1995
DYNA IMPLANT DESIGN
K930868 · DZE
Dyna Dental Engineering BV
Dental · 798d
Cleared Apr 28, 1995
CG-1000 PERSONAL ECG TRANSMITTER
K935909 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 505d
Cleared Apr 28, 1995
NONE-GENERIC
K940724 · HQY
Top Fashion Optical & Sunglasses
Ophthalmic · 434d
Cleared Apr 28, 1995
SMART DOSE(TM)
K943692 · FRN
River Medical, Inc.
General Hospital · 274d
Cleared Apr 28, 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 239d
Cleared Apr 28, 1995
SIMON NITINOL FILTER
K944353 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 241d
Cleared Apr 28, 1995
MD400 A/B/C/D/E/F/G
K944385 · FIP
International Purification Systems, Inc.
Gastroenterology & Urology · 233d
Cleared Apr 28, 1995
ELLMAN VAPOR-VAC II
K944558 · GEX
North American Technical Services Corp.
General & Plastic Surgery · 224d