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
172009–172032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1978
780 UE (BEHIND THE EAR)
K780916 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
PRIMO CE (BEHIND THE EAR)
K780917 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
PRIMO CEDM (BEHIND THE EAR)
K780918 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
M25 PP (BEHIND THE EAR)
K780919 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
MM-CE 11 (BEHIND THE EAR)
K780920 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
MM-CE DM (BEHIND THE EAR)
K780921 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
UM VII (BEHIND THE EAR)
K780922 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
CT5137 HIGH RESOLUTION OPTION
K780928 · JAK
Emi Medical, Inc.
Radiology · 9d
Cleared Jun 14, 1978
5543 INDEPENDENT VIEWING SYSTEM
K780930 · JAK
Emi Medical, Inc.
Radiology · 8d
Cleared Jun 13, 1978
MILK BATH CONCENTRATE
K780258
Sparta Instrument Corp.
General & Plastic Surgery · 118d
Cleared Jun 13, 1978
FIBER OPTIC ADJUSTABLE HEADLIGHT
K780433 · FCT
Cameron-Miller, Inc.
Ophthalmic · 88d
Cleared Jun 13, 1978
HDL CHOLESTEROL
K780659 · CHH
Macomb Chemical Co.
Chemistry · 54d
Cleared Jun 13, 1978
SOLUTIONS FOR RESPIRATORY THERAPY
K780668 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 53d
Cleared Jun 13, 1978
TSH RIA KIT
K780726 · JLW
Amersham Corp.
Chemistry · 41d
Cleared Jun 13, 1978
URINARY CATHETER CARE SET
K780735 · FCM
Shield Laboratories, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 13, 1978
PERALISTIC PUMP MODEL 2000
K780789 · JQW
Innovative Medical Systems, Inc.
Chemistry · 29d
Cleared Jun 13, 1978
SGPT/ALT REAGENT SYSTEM
K780791 · CKA
American Monitor Corp.
Chemistry · 29d
Cleared Jun 13, 1978
TESTOSTERONE RADIOIMMUNOASSAY KIT 125I
K780792 · CDZ
The Upjohn Co.
Immunology · 29d
Cleared Jun 13, 1978
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID
K780797 · DRS
Gould, Inc.
Cardiovascular · 29d
Cleared Jun 13, 1978
GOULD-STATHAM SP1405 PRESSURE MONITOR
K780798 · DSK
Gould, Inc.
Cardiovascular · 29d
Cleared Jun 13, 1978
VITAMIN B12 RADIOASSAY
K780799 · CDD
Amersham Corp.
Chemistry · 29d
Cleared Jun 13, 1978
ISOZYME - ID CPK MARKER
K780801 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 13, 1978
ARMTROL AND FERMTROL
K780802 · JJW
Biotron , Ltd.
Chemistry · 33d
Cleared Jun 13, 1978
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · FFX
Honeywell, Inc.
Gastroenterology & Urology · 27d