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
165577–165600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1981
CC101 ECG MONITORING SYSTEM
K802312 · DSI
Anthro-Metrics Corp.
Cardiovascular · 106d
Cleared Jan 07, 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · FJI
Cordis Corp.
Gastroenterology & Urology · 78d
Cleared Jan 07, 1981
ENGSTROM EMMA ANESTHETIC GAS MONITOR
K802614 · CBS
Lkb Instruments, Inc.
Anesthesiology · 78d
Cleared Jan 07, 1981
DATASON RTL II
K802695 · IYO
General Electric Co.
Radiology · 69d
Cleared Jan 07, 1981
SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
K802708 · IYO
General Electric Co.
Radiology · 68d
Cleared Jan 07, 1981
ARTERIAL BLOOD FILTER BF-37
K802755 · DTM
Delta Medical Industries
Cardiovascular · 65d
Cleared Jan 07, 1981
SIEMENS PHO/SONIC ALPHA 1000
K802759 · IYO
Siemens Gammasonics, Inc.
Radiology · 64d
Cleared Jan 07, 1981
6MV PORT FILM CAPABILITY OPTION
K802808 · IYE
Varian Assoc., Inc.
Radiology · 61d
Cleared Jan 07, 1981
ELECTRON ARC THERAPY
K802809 · IYE
Varian Assoc., Inc.
Radiology · 61d
Cleared Jan 07, 1981
MODEL HEC-7 HEART EVALUATION COMPUTER
K802952 · DPS
Kluwe Corp.
Cardiovascular · 48d
Cleared Jan 07, 1981
I.V. ADDITIVE CAP
K802966 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 47d
Cleared Jan 07, 1981
NUFFIELD ANESTHESIA VENTILATOR SER. 400
K803052 · BSZ
Penlon, Inc.
Anesthesiology · 36d
Cleared Jan 07, 1981
CATH-SECURE
K803062 · KOD
Melissa C. Johnson
Gastroenterology & Urology · 34d
Cleared Jan 06, 1981
DRESSING CHANGE FOR G TUBE
K803115 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 27d
Cleared Jan 06, 1981
REGULATOR VENOSET W/0.22 MICRON IVEX
K810029
Abbott Laboratories
General Hospital
Cleared Jan 05, 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · DHR
Syn-Kit, Inc.
Immunology · 89d
Cleared Jan 05, 1981
TEST KIT FOR DETECTION OF ANTINUCLEAR
K802527 · DHN
Bartels & Stout, Inc.
Immunology · 82d
Cleared Jan 05, 1981
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610 · DER
Hyland Therapeutic Div., Travenol...
Immunology · 76d
Cleared Jan 05, 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · FSM
Associated Medical Products Co.
General & Plastic Surgery · 45d
Cleared Jan 05, 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · FSM
Associated Medical Products Co.
General & Plastic Surgery · 45d
Cleared Jan 05, 1981
NON-CONDUCTIVE ANESTHESIA FACE MASK
K803185 · BSJ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 20d
Cleared Jan 05, 1981
MICROSURG CAUTERY
K810017 · HQO
Medical Products Development, Inc.
Ophthalmic
Cleared Jan 02, 1981
CREST ELECTRONIC WARMING BLANKET
K801253 · DWJ
Penlon, Inc.
Cardiovascular · 219d
Cleared Jan 02, 1981
ATRIAL/VENTRICULAR SEQENTIAL #080-20000
K801799 · LDF
Medical Testing System, Inc.
Cardiovascular · 157d