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
143017–143040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1986
PANAVIA TC, AND PANAVIA OPAQUE
K862232 · EBF
Kuraray Co.
Dental · 48d
Cleared Jul 29, 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247 · JHI
V-Tech, Inc.
Chemistry · 47d
Cleared Jul 29, 1986
IL 482 CO-OXIMETER
K862253 · JKS
Instrumentation Laboratory CO
Chemistry · 46d
Cleared Jul 29, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · CFJ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
K862262 · JHI
Serono Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 29, 1986
ANALYST ANALYTICAL TEST ROTORS
K862274 · CIC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Jul 29, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
K862300 · JGM
Amresco, Inc.
Chemistry · 42d
Cleared Jul 29, 1986
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
K862506 · KIE
Millipore Corp.
Toxicology · 28d
Cleared Jul 29, 1986
LIQUID CHROMATOGRAPHY COLUMNS
K862541 · DPM
Supelco, Inc.
Toxicology · 26d
Cleared Jul 29, 1986
EMIT VALPROIC ACID ASSAY
K862652 · LEG
Syva Co.
Toxicology · 18d
Cleared Jul 29, 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · IZO
General Electric Co.
Radiology · 14d
Cleared Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · LLL
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Jul 29, 1986
DANIEL ORTHO BED LIFT AC
K862738 · ILK
Radco
Physical Medicine · 8d
Cleared Jul 29, 1986
Q50 MEDICAL TREADMILL
K862741 · IOL
Quinton, Inc.
Physical Medicine · 8d
Cleared Jul 28, 1986
LIBAN INTUBATOR
K861026 · CCW
Life Support Devices Co.
Anesthesiology · 132d
Cleared Jul 28, 1986
INHALATOR MODELS 8100, 10100 AND 10200
K862194 · CAW
U.O. Equipment Co.
Anesthesiology · 49d
Cleared Jul 28, 1986
MATTRESS COVER
K862380 · EYQ
Intera Corp.
Gastroenterology & Urology · 34d
Cleared Jul 28, 1986
STOPCOCK
K862691 · FMG
Ram Development
General Hospital · 13d
Cleared Jul 25, 1986
BICONDYLAR TOE PROSTHESIS
K860163
Depuy, Inc.
Orthopedic · 189d
Cleared Jul 25, 1986
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
K861173 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 25, 1986
DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
K861429 · LLZ
Siemens Gammasonics, Inc.
Radiology · 100d
Cleared Jul 25, 1986
SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
K861456 · HMP
Pantheon Products, Inc.
General & Plastic Surgery · 98d
Cleared Jul 25, 1986
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
K861733 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 80d
Cleared Jul 25, 1986
COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
K861941 · IZX
D&R X-Ray Products, Inc.
Radiology · 66d