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
137809–137832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1987
PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT
K874082 · CAF
800-Air-Wats, Inc.
Anesthesiology · 77d
Cleared Dec 23, 1987
BREATHE WITH EEZ (NASAL DILATOR)
K874089 · LWF
Breathe With Eez Corp.
Ear, Nose, Throat · 77d
Cleared Dec 23, 1987
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220 · HJO
Ocular Instruments, Inc.
Ophthalmic · 68d
Cleared Dec 23, 1987
OPMI MD SURGICAL MICROSCOPE
K874241 · FSO
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Dec 23, 1987
WIRE DRESSING
K874310 · LDF
Slocum and Neal, Inc.
Cardiovascular · 64d
Cleared Dec 23, 1987
BTE HEARING AID OTICON MODEL E39PL
K874381 · ESD
Oticon Corp.
Ear, Nose, Throat · 58d
Cleared Dec 23, 1987
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630 · HAO
Downs Surgical , Ltd.
Neurology · 43d
Cleared Dec 23, 1987
MALIS SURGICAL LOUPES
K874845 · HJH
Valley Forge Scientific Corp.
Ophthalmic · 29d
Cleared Dec 23, 1987
DAMON D.E.T.E.C.T IMAGE ENHANCER
K874865 · LLZ
Damon Corp.
Radiology · 26d
Cleared Dec 23, 1987
WOODLYN CLASSIC REFRACTOR, PHOROPTOR
K874900 · HKN
Woodlyn, Inc.
Ophthalmic · 22d
Cleared Dec 23, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K874963 · HNA
Solway, Inc.
Ophthalmic · 21d
Cleared Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 813d
Cleared Dec 22, 1987
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · CGA
Miles Laboratories, Inc.
Chemistry · 225d
Cleared Dec 22, 1987
TELESONIC BODY STIMULATOR
K872606 · IPF
Telesonic, Inc.
Physical Medicine · 173d
Cleared Dec 22, 1987
HVA & HOMOVANILLIC ACID BY HPLC METHOD
K873372 · CDF
Bio-Rad
Chemistry · 120d
Cleared Dec 22, 1987
ECMO-TEMP (TM) BLOOD WARMING DEVICE
K873699 · DWC
Seabrook Medical Systems, Inc.
Cardiovascular · 97d
Cleared Dec 22, 1987
TILSON TRACH GUARD
K873974 · BZA
Beevers Mfg. & Supply, Inc.
Anesthesiology · 84d
Cleared Dec 22, 1987
OPHTHALMIC DISPOSABLE BLADES
K874056 · HNN
Myocure, Inc.
Ophthalmic · 78d
Cleared Dec 22, 1987
INORGANIC PHOSPHORUS
K874472 · CEO
Catachem, Inc.
Chemistry · 50d
Cleared Dec 22, 1987
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625 · DLZ
Syva Co.
Toxicology · 42d
Cleared Dec 22, 1987
WAKO(TM) AUTOKIT LIPASE
K874640 · CHI
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Em Diagnostic Systems, Inc.
Chemistry · 33d
Cleared Dec 22, 1987
MODIFIED PALLADIUM SEED MODEL 100
K874787 · IWI
Theragenics Corp.
Radiology · 29d
Cleared Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628 · LSL
Ortho Diagnostic Systems, Inc.
Microbiology · 168d