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
129145–129168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790 · JHI
Quidel Corp.
Chemistry · 89d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · JHI
Diagnostic Products Corp.
Chemistry · 83d
Cleared Oct 25, 1989
PLASMA CATECHOLAMINES BY HPLC
K894966 · CHQ
Bio-Rad
Chemistry · 79d
Cleared Oct 25, 1989
REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE
K895046 · FPA
Pharmacia Deltec, Inc.
General Hospital · 77d
Cleared Oct 25, 1989
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528 · JJX
Helena Laboratories
Chemistry · 49d
Cleared Oct 25, 1989
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
K895571 · LAN
Tudor Laboratories, Inc.
Toxicology · 49d
Cleared Oct 25, 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · JGS
Technicon Instruments Corp.
Chemistry · 35d
Cleared Oct 24, 1989
DE-BOND 200
K883418 · EKS
Scheu-Dental
Dental · 435d
Cleared Oct 24, 1989
ELECTRONIC PAIN RELIEVERS
K883811 · GZJ
Jetco of America
Neurology · 411d
Cleared Oct 24, 1989
KLEEN TEST BASIN SET
K890039 · JOL
Kleen Test Products
General Hospital · 287d
Cleared Oct 24, 1989
GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
K890107 · FRO
Premium Plastics, Inc.
General & Plastic Surgery · 286d
Cleared Oct 24, 1989
AR-800PA RESPIRATION MODULE
K891486 · BZQ
Nihon Kohden America, Inc.
Anesthesiology · 221d
Cleared Oct 24, 1989
ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)
K892710 · EBG
Prometex, Inc.
Dental · 193d
Cleared Oct 24, 1989
METABOLIC SYSTEMS
K894154 · ISD
Cybex
Physical Medicine · 132d
Cleared Oct 24, 1989
DUMON TRACHEOBRONCHIAL STENT
K894380 · NWA
Bryan Corp.
General & Plastic Surgery · 99d
Cleared Oct 24, 1989
HEARING AID (IN-THE-EAR)
K894428 · ESD
Hearing Aid Express
Ear, Nose, Throat · 99d
Cleared Oct 24, 1989
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
K894486 · GTQ
Biokit USA, Inc.
Microbiology · 98d
Cleared Oct 24, 1989
VARICELLA ZOSTER VIRUS
K894622 · GQW
Bion Ent., Ltd.
Microbiology · 96d
Cleared Oct 24, 1989
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
K894831 · BTI
Equi-Tron Mfg., Inc.
Anesthesiology · 85d
Cleared Oct 24, 1989
OS-1 OCCLUSION SYSTEM - 1
K894839 · BZC
Medical, Inc.
Anesthesiology · 85d
Cleared Oct 24, 1989
MODIFIED HEMOGLOBIN REAGENT SET
K894951 · GKK
Macomb Biotechnology, Inc.
Hematology · 96d
Cleared Oct 24, 1989
DENTIN BONDING SYSTEM
K894994 · KLE
Cosmedent, Inc.
Dental · 77d
Cleared Oct 24, 1989
3M INSTANT FIT CUSTOM EARMOLD
K895134 · ESD
3M Company
Ear, Nose, Throat · 69d
Cleared Oct 24, 1989
ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
K895182 · FAJ
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 74d