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
105985–106008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1994
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
K925510 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 727d
Cleared Oct 27, 1994
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
K925909 · GKZ
Alicia Diagnostics, Inc.
Hematology · 723d
Cleared Oct 27, 1994
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · GIO
Sherwood Medical Co.
Chemistry · 224d
Cleared Oct 27, 1994
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
K941496 · CEK
Solarcare, Inc.
Chemistry · 213d
Cleared Oct 27, 1994
MICROSPORIDIUM CONTROL SET
K943228 · LJG
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Oct 27, 1994
IMMULITE DIGITOXIN
K943235 · LFM
Diagnostic Products Corp.
Toxicology · 113d
Cleared Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
K943313 · LGR
Sigma Diagnostics, Inc.
Toxicology · 108d
Cleared Oct 27, 1994
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
K943407 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 105d
Cleared Oct 27, 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · JOH
Bivona Medical Technologies
Anesthesiology · 62d
Cleared Oct 27, 1994
CARDIOCHEX
K944243 · JJT
Cala Diagnostics
Chemistry · 57d
Cleared Oct 27, 1994
SUNGLASSES
K944394 · HQY
Unique Industries, Inc.
Ophthalmic · 48d
Cleared Oct 27, 1994
SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES
K944783 · HQY
Sun Eyewear Co.
Ophthalmic · 30d
Cleared Oct 27, 1994
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND...
K945034 · DSA
Conmedcorp
Cardiovascular · 14d
Cleared Oct 26, 1994
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)
K930964 · IYO
Acuson Corp.
Radiology · 609d
Cleared Oct 26, 1994
MULE
K934238 · ISD
Penny and Giles Biometrics , Ltd.
Physical Medicine · 422d
Cleared Oct 26, 1994
HOWMEDICA PREMIUM FEMORAL COMPONENT
K936127 · JDI
Howmedica, Inc.
Orthopedic · 307d
Cleared Oct 26, 1994
PRESSURE RELIEF VALVE
K941492 · MNJ
Circulatory Technology, Inc.
Cardiovascular · 212d
Cleared Oct 26, 1994
MMC AMPLIFIER
K943673 · GWL
Melville Software , Ltd.
Neurology · 92d
Cleared Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
K943076 · LLL
Inova Diagnostics, Inc.
Immunology · 119d
Cleared Oct 25, 1994
PRO-STEP LH OVULATION PREDICTION TEST
K943252 · CEP
Disease Detection International, Inc.
Chemistry · 111d
Cleared Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426 · JHI
Princeton BioMeditech Corp.
Chemistry · 43d
Cleared Oct 25, 1994
4 CHANNEL DISPENSER
K944556 · JQW
Tecan U.S., Inc.
Chemistry · 39d
Cleared Oct 21, 1994
MION 525
K926376 · EMA
Mion International Corp.
Dental · 668d
Cleared Oct 21, 1994
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES
K926463 · FQO
Midmark Corp.
General & Plastic Surgery · 666d