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
166633–166656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1980
FINGER PAINGUARD CAT.#193-194
K802015 · FQM
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
PREP SET CAT.#908
K802020 · KXF
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared Sep 09, 1980
CULSWAB CAT.#978 & 979
K802023 · JTW
Pollak (Intl.), Ltd.
Microbiology · 20d
Cleared Sep 09, 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · DXY
Intermedics, Inc.
Cardiovascular · 29d
Cleared Sep 09, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS612
K802044 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 21d
Cleared Sep 09, 1980
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
K802062 · CAT
Hospitak, Inc.
Anesthesiology · 13d
Cleared Sep 09, 1980
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
K802065 · BSO
Portex, Inc.
Anesthesiology · 13d
Cleared Sep 09, 1980
DISP. TRANSDUCER DOMES TD200 & TD300
K802069 · DRS
Bio-Med Corp.
Cardiovascular · 13d
Cleared Sep 09, 1980
VITAL SIGNS PEEP VALVE
K802070 · BYE
Vital Signs, Inc.
Anesthesiology · 13d
Cleared Sep 06, 1980
PA-1 LOW PRESSURE ALARM
K802112
Puritan Bennett Corp.
Cardiovascular · 3d
Cleared Aug 27, 1980
TALEISNIK TOTAL WRIST PROSTHESIS
K800602 · KWM
Dow Corning Wright
Orthopedic · 163d
Cleared Aug 27, 1980
CYBER 120 HEMODIALYZER
K801377 · FJG
Cyberex Corp.
Gastroenterology & Urology · 77d
Cleared Aug 27, 1980
RTM SYSTEM (REMOTE TEMPERATURE MONITOR)
K801423 · FLL
Remote Technologies, Inc.
General Hospital · 71d
Cleared Aug 27, 1980
SSC8 SORENSON SUBCLAVIAN CATHETER
K801478 · FIQ
Sorensen Research
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · KDI
Gambro, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · KDI
Gambro, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · FRN
Critikon Company, LLC
General Hospital · 51d
Cleared Aug 27, 1980
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM.
K801577 · IPF
Inter Med Industries, Inc.
Physical Medicine · 49d
Cleared Aug 27, 1980
GLUCOSE (TRINDER) REAGENT
K801600 · CGA
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 27, 1980
DESERET I.V. FILTER
K801602 · FPB
Hospital Products Co.
General Hospital · 44d
Cleared Aug 27, 1980
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
K801637 · KPK
C.R. Bard, Inc.
Cardiovascular · 41d
Cleared Aug 27, 1980
PERMITE DENTAL AMALGAM ALLOY
K801639 · EJJ
Southern Dental Industries, Inc.
Dental · 41d
Cleared Aug 27, 1980
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
K801642 · KLS
Intl. Diagnostic Technology
Toxicology · 41d
Cleared Aug 27, 1980
TOTAL PARENTERAL NUTRITION SET BAG
K801652 · KPE
Cutter Laboratories, Inc.
General Hospital · 40d