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
163057–163080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1981
KORICLEAN
K812176
Trans World Agency, Inc.
Physical Medicine · 63d
Cleared Oct 02, 1981
SR-ALGICAP
K811867 · ELW
J. Aderer, Inc.
Dental · 93d
Cleared Oct 02, 1981
LOXLEY EMERGENCY CERVICAL COLLAR
K812019 · IQK
Loxley Medical
Physical Medicine · 81d
Cleared Oct 02, 1981
MLA ELECTRA 700
K812124 · JPA
Medical Laboratory Automation...
Hematology · 67d
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 50d
Cleared Oct 02, 1981
ISOCENTRIC NEUTRON THERAPY SYSTEMS
K812337 · IWL
The Cyclotron Corp.
Radiology · 45d
Cleared Oct 02, 1981
OMNIMEDICAL QUAD I
K812400 · JAK
Omnimedical
Radiology · 43d
Cleared Oct 02, 1981
DELTASCAN 2060 CT SCANNER
K812410 · JAK
Technicare Corp.
Radiology · 42d
Cleared Oct 02, 1981
CI-TROL HEPARIN CONTROLS, LOW/HIGH
K812424 · KFF
American Dade
Hematology · 39d
Cleared Oct 02, 1981
UNI-THANE
K812448 · KKX
Unicare Systems, Inc.
General Hospital · 35d
Cleared Oct 02, 1981
OPRAFLEX
K812501 · FRO
Selomas, Inc.
General & Plastic Surgery · 32d
Cleared Oct 02, 1981
CARDIAC REVIEW STATION
K812515 · DXG
Diasonics, Inc.
Cardiovascular · 30d
Cleared Oct 02, 1981
SURGICAL BLADES & SCAPELS (SMPL. W/510K)
K812516 · GES
Needle Industries(Usa), Inc.
General & Plastic Surgery · 30d
Cleared Oct 02, 1981
SUNTANNING DEVICE (SEPAR. FROM K812225)
K812521 · FTC
Klafs Sunlight Corp.
General & Plastic Surgery · 30d
Cleared Oct 02, 1981
MEZLOCILLIN 75 MCG. SENSITIVITY DISCS
K812525 · JTN
Difco Laboratories, Inc.
Microbiology · 30d
Cleared Oct 02, 1981
SURGICAL RETRACTOR & ELASTIC STAYS, DISP
K812562 · GDG
Humboldt Products
General & Plastic Surgery · 24d
Cleared Oct 02, 1981
LABCER FIBRINOGEN ASSAY KIT & CALIBR.
K812570 · KQJ
Sherwood Medical Co.
Hematology · 23d
Cleared Oct 02, 1981
ELEGANCE
K812578 · ESD
Qualitone
Ear, Nose, Throat · 23d
Cleared Oct 02, 1981
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
K812593 · CGS
Harleco
Chemistry · 21d
Cleared Oct 02, 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
K812594 · CIJ
Harleco
Chemistry · 21d
Cleared Oct 02, 1981
SQC BUFFER
K812601 · JJS
Transidyne General Corp.
Chemistry · 18d
Cleared Oct 02, 1981
BIOVATION URINALYSIS REPORTER
K812604 · JQP
Biovation, Inc.
Chemistry · 17d
Cleared Oct 02, 1981
FIBER OPTIC LIGHT SOURCE I
K812605 · EAY
Venture Technology, Inc.
Dental · 17d
Cleared Oct 02, 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · FJS
Quinton, Inc.
Gastroenterology & Urology · 17d