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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145441–145464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1986
ABL330 ACID BASE LABORATORY
K860057 · CHL
Radiometer America, Inc.
Chemistry · 58d
Cleared Mar 05, 1986
ENCORE PROLACTIN REAGENT
K860221 · CFT
Hybritech, Inc.
Chemistry · 42d
Cleared Mar 05, 1986
CASTLE 7538 FLOOR LOADING WASHER
K860263 · LDS
Castle Co.
General Hospital · 37d
Cleared Mar 05, 1986
ELLIK EVACUATOR
K860266 · KQT
R. J. Ltd., Ind.
Gastroenterology & Urology · 37d
Cleared Mar 05, 1986
IL TEST PHENYTOIN
K860286 · DIP
Allied Instrumentation Laboratory
Toxicology · 36d
Cleared Mar 05, 1986
ACID PHOSPHATASE REAGENT SET
K860476 · CKE
Sterling Diagnostics, Inc.
Chemistry · 26d
Cleared Mar 05, 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490 · JHI
Medix Biotech, Inc.
Chemistry · 23d
Cleared Mar 05, 1986
SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE
K860509 · FTC
Ecomatic GmbH, Frankfurt, F.R.G.
General & Plastic Surgery · 22d
Cleared Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · JHI
Hybritech, Inc.
Chemistry · 21d
Cleared Mar 05, 1986
NORDIC SUN 24 LAMP TANNING BED
K860566 · FTC
Nordic Sun Corporation of America
General & Plastic Surgery · 19d
Cleared Mar 05, 1986
NORDIC SUN HOME TANNING UNIT
K860567 · FTC
Nordic Sun Corporation of America
General & Plastic Surgery · 19d
Cleared Mar 05, 1986
MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
K860598 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 14d
Cleared Mar 05, 1986
MARKOPTIC IMPROVED ARTHROSCOPE
K860607 · HRX
Markoptic
Orthopedic · 14d
Cleared Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 231d
Cleared Mar 04, 1986
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · JWX
American Micro Scan
Microbiology · 131d
Cleared Mar 04, 1986
RIGIDENT CREAM
K854430 · KOT
Armkel, LLC
Dental · 119d
Cleared Mar 04, 1986
STICKY WAX
K854527 · EGD
The Hygenic Corp.
Dental · 111d
Cleared Mar 04, 1986
PREMIUM FLEXI-TOUGH
K854530 · EGD
The Hygenic Corp.
Dental · 111d
Cleared Mar 04, 1986
UROTEC CLOSED IRRIGATIION SYRINGE
K854625 · KOD
Urotec Systems Corp.
Gastroenterology & Urology · 106d
Cleared Mar 04, 1986
API 50 CHB (CULTURE MEDIA)
K854732 · JST
Dms Products, Inc.
Microbiology · 99d
Cleared Mar 04, 1986
HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
K854795 · EIS
Fran Hazelton Co.
Dental · 92d
Cleared Mar 04, 1986
CHAMELEON BONDING KIT
K854803 · EBF
Pentron Corp.
Dental · 92d
Cleared Mar 04, 1986
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
K854834 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 04, 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · EWO
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d