FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162217–162240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 02, 1981
VASCULAB #R12B
K812608 · DSF
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
VASCULAB #VSC21
K812609 · JOM
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · CDP
Kallestad Laboratories, Inc.
Chemistry · 17d
Cleared Oct 02, 1981
VITROGEN TM 100
K812617 · KIT
Collagen Corp.
Chemistry · 17d
Cleared Oct 02, 1981
ASSURE NATURAL FIT TAMPON
K812618 · HIL
Personal Products Co.
Obstetrics & Gynecology · 17d
Cleared Oct 02, 1981
ANEMIA CONTROL
K812635 · JJY
Environmental Chemical Specialties
Chemistry · 17d