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
127129–127152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1990
ENZYMUN TEST(R) LH
K900779 · CEP
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 03, 1990
TECHNICON AXON SYSTEM REAGENT METHODS
K900905 · CKA
Technicon Instruments Corp.
Chemistry · 35d
Cleared Apr 03, 1990
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K901057 · BZG
Spirometrics, Inc.
Anesthesiology · 28d
Cleared Apr 03, 1990
ENZYMUN TEST(R) INSULIN
K901135 · CFP
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1990
ABC HANDPIECE ADAPTER
K901248 · HAM
Beacon Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Apr 03, 1990
CEDIA (TM) CORTISOL ASSAY
K901296 · CGR
Microgenics Corp.
Chemistry · 14d
Cleared Apr 03, 1990
VITAL SURGICAL GLOVES
K901359 · KGO
Mastervest Corp. Sdn Bhd.
General Hospital · 11d
Cleared Apr 02, 1990
WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
K895085 · EBZ
Lustgarten Multi-Tech International,...
Dental · 231d
Cleared Apr 02, 1990
MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT
K895347 · GEX
Lasag Medical Lasers
General & Plastic Surgery · 213d
Cleared Apr 02, 1990
TEMPORARY DENTAL CEMENT
K895487 · EMA
Dentsply Intl.
Dental · 213d
Cleared Apr 02, 1990
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · HDB
Hollister, Inc.
Obstetrics & Gynecology · 192d
Cleared Apr 02, 1990
DOPPLER OPTION FOR PLATINUM
K900002 · DXK
Philips Medical Systems North...
Cardiovascular · 90d
Cleared Apr 02, 1990
SPECTRASTIM 2000 MUSCLE STIMULATOR
K900029 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 89d
Cleared Apr 02, 1990
SIMULTEST IMK PLUS(TM)
K900078 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 88d
Cleared Apr 02, 1990
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
K900117 · EJH
D.C. Dental Specialties
Dental · 83d
Cleared Apr 02, 1990
LINGUAL SHEATH
K900184 · EJF
Ormco Corp.
Dental · 76d
Cleared Apr 02, 1990
GOLD CIRCLE COIN
K900357 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
SAXON WET LUBE
K900358 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
EMBRACE
K900359 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
SAXON ULTRA THIN
K900360 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
RADIOGRAPHIC INTENSIFYING SCREEN
K901014 · EAM
Infab Corp.
Radiology · 28d
Cleared Apr 02, 1990
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
K901075 · DBF
London Diagnostics, Inc.
Immunology · 25d
Cleared Apr 02, 1990
BETA-2 MICROGLOBULIN EIA
K901333 · JZG
Serex, Inc.
Immunology · 13d
Cleared Mar 30, 1990
MANUAL RESUSCITATOR
K895589 · BTM
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 196d