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

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176,076 results
167161–167184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1980
AMPCO SKIN SCRUB TRAYS
K801332 · FRG
Associated Medical Products Co.
General Hospital · 17d
Cleared Jun 20, 1980
B-D FILTER NEEDLE
K801343 · FPB
Bd Becton Dickinson Vacutainer...
General Hospital · 15d
Cleared Jun 20, 1980
MODEL 336B HEARING AID
K801367 · ESD
Communications, Inc.
Ear, Nose, Throat · 10d
Cleared Jun 17, 1980
SOLARIUM, MODEL 6040A
K800366
Blendette Intl. , Ltd.
Radiology · 118d
Cleared Jun 17, 1980
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
K800822 · FAP
Kli
Gastroenterology & Urology · 64d
Cleared Jun 17, 1980
MEDEFOAM-2
K800840 · KTA
Medefield Pty. , Ltd.
Radiology · 63d
Cleared Jun 17, 1980
MEDEFIZZ A & MEDEFIZZ B
K800843 · KTA
Medefield Pty. , Ltd.
Radiology · 63d
Cleared Jun 17, 1980
BRONZAGE TANNING SYSTEM
K800845
Bronzage Rapide
Radiology · 63d
Cleared Jun 17, 1980
ANESTHESIA EXTENSION TUBES
K800877 · FPK
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
SECONDARY I.V. TUBING SETS
K800878 · FPA
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
CLEAR PLASTIC CONNECTING TUBES
K800879 · FPK
Harvard Laboratories
General Hospital · 61d
Cleared Jun 17, 1980
TANIT COMMERCIAL SUNTAN BOOTH
K801017 · FTC
Tanit, Inc.
Radiology · 48d
Cleared Jun 17, 1980
ULTRA-CHEK PACEMAKER MONITOR
K801022 · KRE
Powers Medical Systmes
Cardiovascular · 48d
Cleared Jun 17, 1980
3M STEAM STERILIZATION INDICATOR
K801057 · JOJ
3M Company
General Hospital · 42d
Cleared Jun 17, 1980
STRAITH NASAL SPLINT
K801072 · FYI
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Jun 17, 1980
STRAITH NASAL IMPLANT
K801074 · FZE
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Jun 17, 1980
F.R.C. APPARATUS
K801088 · BZC
Hogan/Cologne Ent.
Anesthesiology · 40d
Cleared Jun 17, 1980
ANALOR FOUR-ORAL SURGERY MODEL
K801101 · BZE
Narco Mckesson Co.
Anesthesiology · 39d
Cleared Jun 17, 1980
COMPALOR-ORAL SURGERY MODEL
K801102 · BSZ
Narco Mckesson Co.
Anesthesiology · 39d
Cleared Jun 17, 1980
COBAS REAGENT FOR BUN
K801116 · CDQ
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jun 17, 1980
NYLON LIGATING CLIP
K801124 · FZP
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Jun 17, 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133 · LBS
Union Carbide Corp.
Chemistry · 36d
Cleared Jun 17, 1980
EMIT VALPROIC ACID CONTROL
K801206 · LAS
Syva Co.
Toxicology · 29d
Cleared Jun 17, 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · JQP
Miles Laboratories, Inc.
Chemistry · 28d