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
160153–160176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1982
ANTRUM TROCARS
K822168 · KTE
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
MICROSURGICAL EAR PICKS
K822176 · JYT
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
MOUTH GAGS
K822183 · KBN
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT METAL TONGUE DEPRESSORS
K822184 · KBL
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
BECKMAN ADENOID CURRETTE
K822189 · KBJ
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT ELEVATORS
K822190 · KAD
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
NEEDLE HOLDERS
K822197 · LCR
Kelleher Corp.
Toxicology · 24d
Cleared Aug 16, 1982
TOTAL IGE DISCS
K822206 · DGC
Kallestad Laboratories, Inc.
Chemistry · 21d
Cleared Aug 16, 1982
STERILE HD PAN SET
K822211 · FRG
Hospital Disposables, Inc.
General Hospital · 21d
Cleared Aug 16, 1982
VOLUMETRIC CONTROLLER
K822216 · BTC
Quest Medical, Inc.
Anesthesiology · 21d
Cleared Aug 16, 1982
EMPI SINGLE USE
K822224 · GXY
Empi
Neurology · 20d
Cleared Aug 16, 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · CGJ
Corning Medical & Scientific
Chemistry · 20d
Cleared Aug 16, 1982
ACA URINARY PROTEIN CALIBRATOR
K822232 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 20d
Cleared Aug 16, 1982
UREA NITROGEN REAGENT SET (MOD. BERTHEL
K822237 · CDL
Sterling Biochemical, Inc.
Chemistry · 19d
Cleared Aug 16, 1982
VARIOUS TYPES OF TONSILS HEMOSTATS
K822263 · HRQ
Kelleher Corp.
General & Plastic Surgery · 18d
Cleared Aug 16, 1982
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · GWN
Kelleher Corp.
Neurology · 18d
Cleared Aug 16, 1982
VARIOUS TYPES OF ENT ELEVATORS
K822270 · KAD
Kelleher Corp.
Ear, Nose, Throat · 18d
Cleared Aug 16, 1982
VANCOMYCIN FLUORESCENT IMMUNOASSAY
K822308 · LEH
American Diagnostic Corp.
Toxicology · 13d
Cleared Aug 16, 1982
C-REACTIVE PROTEIN TEST KIT
K822332 · JIS
Sclavo, Inc.
Chemistry · 12d
Cleared Aug 16, 1982
HEMATOXYLIN STAIN SOLUTION
K822352 · HYJ
Fisher Scientific Co., LLC
Pathology · 10d
Cleared Aug 16, 1982
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Aug 16, 1982
SONOLINE 1000, 8008 AND 8080
K827503
Siemens Medical Solutions USA, Inc.
Radiology · 18d