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

Filters: Cleared only ×
176,076 results
168769–168792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1979
ANTI-HUMAN KAPPA SERUM
K791284 · DFH
Diagnostica, Inc.
Immunology · 140d
Cleared Nov 27, 1979
OMNICOR PROGRAMMER MODEL 222C
K791419 · KRG
Cordis Corp.
Cardiovascular · 133d
Cleared Nov 27, 1979
SCI-PHARM POLIFIL ANTERIOR RESTORATIVE
K791602 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 105d
Cleared Nov 27, 1979
VDC
K791756 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 83d
Cleared Nov 27, 1979
HARLECO BRAND CLINICARD LIPASE TEST SET
K791922 · CET
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 62d
Cleared Nov 27, 1979
UNIFOCAL 1 UNIPOLAR DEMAND R WAVE
K791955 · DXY
American Pacemaker Corp.
Cardiovascular · 57d
Cleared Nov 27, 1979
1 STEP
K792003 · DYH
Betta Dental, Inc.
Dental · 55d
Cleared Nov 27, 1979
CORDIA RF
K792061 · DHR
Cordis Corp.
Immunology · 43d
Cleared Nov 27, 1979
CHRONAEROBIC (CA-1)
K792122 · DRT
Stanford Scientific, Inc.
Cardiovascular · 33d
Cleared Nov 27, 1979
CO 2 METER
K792155 · CCK
Boehringer Laboratories
Anesthesiology · 34d
Cleared Nov 27, 1979
FISCH DRILL SYSTEM
K792159 · ERL
Jedmed Instrument Co.
Ear, Nose, Throat · 29d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · CDX
Abbott Laboratories
Immunology · 27d
Cleared Nov 27, 1979
SERIES S (BEHIND-THE-EAR-HEARING AID)
K792198 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 27, 1979
UNIFOCAL 2-UNIPOLAR & BIPOLAR
K792199 · DXY
American Pacemaker Corp.
Cardiovascular · 26d
Cleared Nov 27, 1979
DURAZYME GOT/AST
K792208 · CIT
American Monitor Corp.
Chemistry · 25d
Cleared Nov 27, 1979
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214 · BWF
Starkey Laboratories, Inc.
Anesthesiology · 25d
Cleared Nov 27, 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · BWF
Airlife, Inc.
Anesthesiology · 22d
Cleared Nov 27, 1979
MISTY BEBULIZER
K792218 · CAF
Airlife, Inc.
Anesthesiology · 22d
Cleared Nov 27, 1979
UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR
K792232 · DXY
American Pacemaker Corp.
Cardiovascular · 22d
Cleared Nov 27, 1979
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234 · CDT
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Nov 27, 1979
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · BSK
Shiley, Inc.
Anesthesiology · 18d
Cleared Nov 27, 1979
CIRCAPAK
K792268 · BZO
Respiratory Care, Inc.
Anesthesiology · 18d
Cleared Nov 27, 1979
USHER'S MARLEX TUBULAR MESH
K792281 · FTL
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Nov 27, 1979
LS-100
K792302 · EFB
Midwest
Dental · 11d