Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78673–78696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2001
V*CARE MANUAL RESUSCITATOR
K012842 · BTM
Ventlab Corp.
Anesthesiology · 26d
Cleared Sep 18, 2001
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
K012899 · LZA
Best Manufacturing Company
General Hospital · 20d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · LCD
Randox Laboratories, Ltd.
Toxicology · 74d
Cleared Sep 17, 2001
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · FLL
Radiant Innovation, Inc.
General Hospital · 164d
Cleared Sep 17, 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 115d
Cleared Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES,...
K011911 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Sep 17, 2001
FIRST SPEP
K012032 · DYH
Bisco, Inc.
Dental · 80d
Cleared Sep 17, 2001
CLINCARE LATEX SURGEON'S GLOVE
K012067 · KGO
Ttk Healthcare , Ltd.
General Hospital · 77d
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · HTY
Opus Medical, Inc.
Orthopedic · 73d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · JXM
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Sep 17, 2001
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN...
K012558 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 40d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 19d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · HSD
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Sep 14, 2001
VERTEX ETCHANT
K010849 · EBF
Apex Dental Materials, Inc.
Dental · 177d
Cleared Sep 14, 2001
E-STETH ELECTRONIC STETHOSCOPE
K011898 · DQD
E-Med Innovations, Inc.
Cardiovascular · 88d
Cleared Sep 14, 2001
ALLERSHARP ALLERGY SKIN TESTER
K011979 · SCL
Hmb Medical Concepts, Ltd.
General Hospital · 81d
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103 · LNJ
Applied Spectral Imaging , Ltd.
Pathology · 71d
Cleared Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
K012386 · GGP
American Diagnostica, Inc.
Hematology · 49d
Cleared Sep 14, 2001
BIOTEQUE SCALP VEIN SET
K012526 · FPA
Bioteque Corp.
General Hospital · 39d
Cleared Sep 14, 2001
CARIES DETECTOR
K012733 · LFC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL NEW BOND
K012734 · KLE
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL DC CEMENT
K012735 · EMA
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CHROMA ZONE COLOR STAIN
K012737 · EBF
Kuraray Medical, Inc.
Dental · 31d