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
132769–132792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · JHY
Bd Becton Dickinson Vacutainer...
Chemistry · 115d
Cleared Feb 23, 1989
DSL 7800 ACTIVE CORTISOL
K884689 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 107d
Cleared Feb 23, 1989
TECA/MEDELEC 'CONCEPT' P420
K884870 · GWF
Teca, Inc.
Neurology · 94d
Cleared Feb 23, 1989
BP-408 MARK II
K884885 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
BP-308 MARK II
K884896 · DPS
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
JEDMED KP6 COLPOSCOPE
K884934 · HEX
Jedmed Instrument Co.
Obstetrics & Gynecology · 87d
Cleared Feb 23, 1989
VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER
K884949 · EJK
Ortho Source
Dental · 90d
Cleared Feb 23, 1989
Q750 ELECTROCARDIOGRAPH
K885000 · LOS
Quinton, Inc.
Cardiovascular · 84d
Cleared Feb 23, 1989
SIEMENS INTRAVAGINAL TRANSDUCER
K885061 · HEM
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 79d
Cleared Feb 23, 1989
HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K885186 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 71d
Cleared Feb 23, 1989
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
K885198 · JLX
Icn Biomedicals, Inc.
Chemistry · 69d
Cleared Feb 23, 1989
NUPREP
K885306 · DRX
Weaver & Co.
Cardiovascular · 58d
Cleared Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · CIN
Helena Laboratories
Chemistry · 57d
Cleared Feb 23, 1989
BIOTRACK APTT CONTROLS
K890051 · GIT
Biotrack, Inc.
Hematology · 48d
Cleared Feb 23, 1989
LIFEPAK 10 DEFIBRILLATOR/MONITOR
K890079 · LDD
Physio-Control Corp.
Cardiovascular · 50d
Cleared Feb 23, 1989
SAFEPETTE DISPENSER
K890109 · JKA
Safe-Tec Clinical Products, Inc.
Chemistry · 44d
Cleared Feb 23, 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · NFB
Salter Labs
Anesthesiology · 35d
Cleared Feb 23, 1989
DELFIA PROGESTERONE KIT
K890428 · JLS
Pharmacia, Inc.
Chemistry · 28d
Cleared Feb 23, 1989
HEMORRHAGE OCCLUDOR
K890447 · GDW
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery · 27d
Cleared Feb 23, 1989
CARDIOBEEPER IV
K890461 · DXH
Survival Technology, Inc.
Cardiovascular · 24d
Cleared Feb 23, 1989
SURGICAL GOWNS
K890474 · FYA
Victoria Slipper Retail & Mfg., Co.
General Hospital · 23d
Cleared Feb 23, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
K890561 · CFQ
Atlantic Antibodies
Immunology · 30d
Cleared Feb 22, 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · EWO
Resound Corp.
Ear, Nose, Throat · 149d
Cleared Feb 22, 1989
SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
K884159 · DYB
Mallinckroot, Inc.
Cardiovascular · 141d