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
174097–174120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1977
DIALYZER, ULTRADIFFUSER, DISPOSABLE
K770858 · FJG
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 14, 1977
FLU VEN 0160
K770863 · FPA
Venospital, Inc.
General Hospital · 34d
Cleared Jun 14, 1977
MONITOR, PACEMAKER
K770865 · DTC
Adcor Electronics, Inc.
Cardiovascular · 34d
Cleared Jun 14, 1977
DIALYZER, FIBER, HOLLOW
K770867 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Jun 14, 1977
TSH RADIOIMMUNOASSAY
K770892 · JLW
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Jun 14, 1977
CLASP RIA KIT, HTSH
K770915 · JLW
E. R. Squibb & Sons, Inc.
Immunology · 26d
Cleared Jun 14, 1977
PEDIATRIC BLOOD CULTURE BOTTLES
K770957 · JTW
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Jun 14, 1977
BANDAGE, UNIPRESS, CLARION
K770958 · FQM
Sherwood Medical Industries
General Hospital · 18d
Cleared Jun 14, 1977
BOUGIE, FILIFORM, JACKSON
K770959 · KBI
V. Mueller O.V. Baxter Healthcare Corp.
Ear, Nose, Throat · 18d
Cleared Jun 14, 1977
HEARING AID, SERIES R
K770960 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared Jun 14, 1977
CARDIOVASCULAR SPRING GUIDES
K770977 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 14d
Cleared Jun 14, 1977
NERVE STIMULATOR, MOLEL NO. FB-800
K770987 · GZI
Output, Inc.
Neurology · 14d
Cleared Jun 14, 1977
FOAM ECG ELECTRODE, 2060 AND 2061
K770988 · DRX
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 14d
Cleared Jun 14, 1977
TS-100 TEST SYSTEM
K771014 · KRC
Delta Medical Industries
Cardiovascular · 8d
Cleared Jun 14, 1977
CITADEL CPAP ACCESSORY KIT
K771017 · CAI
Sherwood Medical Industries
Anesthesiology · 8d
Cleared Jun 14, 1977
LUNG-MECHANICS MONITOR
K771019 · BZQ
Research Development Corp.
Anesthesiology · 8d
Cleared Jun 14, 1977
AUTO-CLIP
K771021 · DSS
Axiom Medical, Inc.
Cardiovascular · 8d
Cleared Jun 09, 1977
BANDAGE COMPRESS 2, 3, 4
K770410 · NAB
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 97d
Cleared Jun 08, 1977
CHOLESTEROL REAGENT
K770483 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 86d
Cleared Jun 08, 1977
QUANTI. COLORI. DET. OF SERUM IRON
K770495
Sigma Chemical Co.
Chemistry · 86d
Cleared Jun 08, 1977
CALCIUM/MAGNESIUM ANALYZER
K770570 · JFN
Beckman Instruments, Inc.
Chemistry · 75d
Cleared Jun 08, 1977
TYGON PAC-STOPCOCKS
K770708 · FMG
Norton Performance Plastics Corp.
General Hospital · 51d
Cleared Jun 08, 1977
BURETTE SET, 2C0132
K770763 · FPA
Travenol Laboratories, S.A.
General Hospital · 43d
Cleared Jun 08, 1977
FLUORETEC-M
K770833 · GMY
Pfizer, Inc.
Microbiology · 33d