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
165841–165864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1980
TECNOL TELEMETRY UNIT POUCH
K802849 · DRG
Tecnol New Jersey Wound Care, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1980
ARGYLE HEMATURIA BALLOON CATHETER
K802875 · KOD
Sherwood Medical Co.
Gastroenterology & Urology · 29d
Cleared Dec 16, 1980
MODEL EEG 4221
K802887 · GWQ
Nihon Kohden America, Inc.
Neurology · 29d
Cleared Dec 16, 1980
ELECTRONIC DIGITAL THERMOMETER
K802897 · KPD
Philip J. Teders
General Hospital · 29d
Cleared Dec 16, 1980
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · KRI
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Dec 15, 1980
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE
K802279 · EWG
Vida, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 15, 1980
CMR 300, ROWATER TREATMENT UNIT
K802474 · FIP
U-Marc, Inc.
Gastroenterology & Urology · 67d
Cleared Dec 12, 1980
UPPER EXTREMITY TRACTION DEVICE
K803021 · HST
Orthopedic Systems, Inc.
Neurology · 16d
Cleared Dec 11, 1980
HEMATIC BLOOD MIXER
K802608 · KSQ
Helmer Labs, Inc.
Hematology · 51d
Cleared Dec 11, 1980
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · CFE
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Dec 11, 1980
CREATININE STANDARDS
K802631 · JIS
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
BUN/GLUCOSE STANDARDS
K802633 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · JOJ
Organon, Inc.
General Hospital · 50d
Cleared Dec 11, 1980
PLATELET COUNTING KIT
K802636 · GKL
Streck Laboratories, Inc.
Hematology · 49d
Cleared Dec 11, 1980
GAMMEX SURGICAL GLOVES
K802641 · KGO
Ansell, Inc.
General Hospital · 48d
Cleared Dec 11, 1980
SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.
K802704 · IYO
Cgr Medical Corp.
Radiology · 41d
Cleared Dec 11, 1980
GLYCOHEMOGLOBIN IN WHOLE BLOOD
K802721 · LCP
Sigma Chemical Co.
Hematology · 41d
Cleared Dec 11, 1980
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS
K802725 · KZR
Varian Assoc., Inc.
Chemistry · 41d
Cleared Dec 11, 1980
125I-TESTOSTERONE TEST SET
K802728 · CDZ
Wien Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · GGK
Miles Laboratories, Inc.
Chemistry · 38d
Cleared Dec 11, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)
K802753 · JSK
Oxoid U.S.A., Inc.
Chemistry · 38d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0765
K802769 · FCT
Aspen Laboratories, Inc.
Ophthalmic · 38d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0766766
K802770 · FCT
Aspen Laboratories, Inc.
Ophthalmic · 38d