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
126793–126816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1990
BLOOD GAS CALIBRATION STANDARD
K900819 · LCH
Cryogenic Rare Gas Laboratories, Inc.
Chemistry · 63d
Cleared Apr 25, 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · LCM
Abbott Laboratories
Toxicology · 56d
Cleared Apr 25, 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · EJF
Ivoclar North America, Inc.
Dental · 50d
Cleared Apr 25, 1990
FILLOCK REAMER
K901097 · DZA
Ivoclar North America, Inc.
Dental · 49d
Cleared Apr 25, 1990
PROTOCOL (ALLOY)
K901099 · EJS
Ivoclar North America, Inc.
Dental · 49d
Cleared Apr 25, 1990
STERILE LATEX PATIENT EXAMINATION GLOVES
K901116 · LYY
Medi Tex, Inc.
General Hospital · 47d
Cleared Apr 25, 1990
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
K901241 · LNH
Medical Advances, Inc.
Radiology · 41d
Cleared Apr 25, 1990
WIRONTOM CLASP WIRE
K901257 · EJW
Ivoclar North America, Inc.
Dental · 41d
Cleared Apr 25, 1990
COULTER TOTAL BILIRUBIN REAGENT
K901266 · CIG
Coulter Corp.
Chemistry · 40d
Cleared Apr 25, 1990
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
K901298 · CGX
Olympus Corp.
Chemistry · 36d
Cleared Apr 25, 1990
HYDRA VIEW IMAGING SYSTEM
K901323 · JAA
Mallinckrodt Group, Inc.
Radiology · 35d
Cleared Apr 25, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · KNK
Technicon Instruments Corp.
Chemistry · 14d
Cleared Apr 25, 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · CKA
American Research Products Co.
Chemistry · 13d
Cleared Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · DQO
C.R. Bard, Inc.
Cardiovascular · 256d
Cleared Apr 23, 1990
CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
K895775 · KTB
Medtronic Vascular
Physical Medicine · 208d
Cleared Apr 23, 1990
B-SCAN 10 MHZ PROBE
K896038 · ITX
Teknar, Inc.
Radiology · 189d
Cleared Apr 23, 1990
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · EBC
Dentsply Intl.
Dental · 171d
Cleared Apr 23, 1990
PARACERVICAL/PUDENDAL TRAYS
K896799 · CAZ
Westmark, Sterile Packing Systems,...
Anesthesiology · 143d
Cleared Apr 23, 1990
TRACHAEL SUCTION SET
K896887 · BSY
Orion Life Systems, Inc.
Anesthesiology · 136d
Cleared Apr 23, 1990
WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)
K897089 · HQZ
Inno-Lite Co., Inc.
Ophthalmic · 124d
Cleared Apr 23, 1990
HYDRASORB(TM)
K897102 · JOH
Avitar, Inc.
Anesthesiology · 123d
Cleared Apr 23, 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168 · LJS
Vygon Corp.
General Hospital · 117d
Cleared Apr 23, 1990
THAYER SUCTION EVACUATION CONDENSATE COLLECTION
K900047 · BYH
Thayer Medical Corp.
Anesthesiology · 110d
Cleared Apr 23, 1990
KIT PAK IRRIGATION TRAY
K900148 · EYN
Kit Pak, Inc.
General & Plastic Surgery · 102d