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
171985–172008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1978
CRYOCYTE PACK
K780354 · KSR
Travenol Laboratories, S.A.
Hematology · 103d
Cleared Jun 14, 1978
PODIATRIC MATERIAL
K780391 · MNE
Crown Delta Corp.
Physical Medicine · 96d
Cleared Jun 14, 1978
SPHERISTEM TOTAL HIP PROSTHESIS
K780497 · JDG
American Ortomed Corp.
Orthopedic · 78d
Cleared Jun 14, 1978
L-12, L-21, AND L-22 ELECTRODES
K780569 · DTB
Coratomic, Inc.
Cardiovascular · 64d
Cleared Jun 14, 1978
EXTRACORPEAL CARDIOTOMY BLOOD FILTER
K780653 · JOD
Cobe Laboratories, Inc.
Cardiovascular · 56d
Cleared Jun 14, 1978
B-HCG-RIA
K780679 · JHI
Nuclear Medical Systems, Inc.
Immunology · 51d
Cleared Jun 14, 1978
ARTERIOVENOUS BLOOD TUBING SETS
K780681 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 51d
Cleared Jun 14, 1978
T4-RIA KIT
K780707 · CDX
Clinical Bioresearch
Chemistry · 50d
Cleared Jun 14, 1978
TECHNICON BGII ANALYZER
K780716 · CHL
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jun 14, 1978
NEONATAL MONITOR
K780754 · DXN
Applied Medical Research
Cardiovascular · 36d
Cleared Jun 14, 1978
M. 1336S CATHODE-RAY TUBE DISPLAY
K780782 · DXJ
Hewlett-Packard Co.
Radiology · 33d
Cleared Jun 14, 1978
DILUTOR TRANSPORTER
K780785 · JQW
Hyland Therapeutic Div., Travenol...
Chemistry · 33d
Cleared Jun 14, 1978
DENTURE RELINE MATERIAL
K780786 · EBI
Dentsply Intl.
Dental · 33d
Cleared Jun 14, 1978
HYGIENIC ANCHORINGS
K780804 · ECI
Hygienic Dental Mfg., Co., The
Dental · 34d
Cleared Jun 14, 1978
MLA ELECTRA 750 COAGULATION TIMER
K780810 · JPA
Medical Laboratory Automation...
Hematology · 27d
Cleared Jun 14, 1978
ISOTONIC BUFFERED SALINE
K780830 · GIF
Harleco
Hematology · 26d
Cleared Jun 14, 1978
ESTILUX MICROFILL
K780832 · EBF
Degussa Dental, Inc.
Dental · 23d
Cleared Jun 14, 1978
ESTIC MICROFILL
K780833 · EBF
Degussa Dental, Inc.
Dental · 23d
Cleared Jun 14, 1978
DIAMOND STONES
K780864 · DZP
Venture Technology, Inc.
Dental · 15d
Cleared Jun 14, 1978
ARTERIAL LINE KIT
K780871 · GDY
Argon Medical Corp.
General & Plastic Surgery · 15d
Cleared Jun 14, 1978
THYMUNE-M
K780873 · DDC
Burroughs Wellcome Co.
Immunology · 15d
Cleared Jun 14, 1978
THYMUNE-T
K780874 · DDC
Burroughs Wellcome Co.
Immunology · 15d
Cleared Jun 14, 1978
PM 25 PP (BODY AID)
K780914 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
780 SE (BEHIND THE EAR)
K780915 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d