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
167905–167928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1979
COMPOSITE RESTORATIVE, PASTE/TYPE
K792140 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 39d
Cleared Nov 30, 1979
ATOMIC SPECTROSCOPY SYSTEM
K792146 · JXR
The Perkin-Elmer Corp.
Radiology · 39d
Cleared Nov 30, 1979
LAB-TEK ANA TEST KIT
K792184 · DHN
Miles Laboratories, Inc.
Immunology · 32d
Cleared Nov 30, 1979
STREP CULTURETTE
K792201 · JSN
Marion Health & Safety, Inc.
Microbiology · 28d
Cleared Nov 30, 1979
PACESETTER MODEL 350
K792223 · DTE
Cynergy
Cardiovascular · 25d
Cleared Nov 30, 1979
CRPTELL
K792238 · DCK
Central Biological Co.
Immunology · 23d
Cleared Nov 30, 1979
PELIMIT
K792241 · IRN
Colmed, Ltd.
Physical Medicine · 23d
Cleared Nov 30, 1979
TAYLOR PATIENT TRANSFER BOARD
K792247 · IKX
Taylor Medical Equipment
Physical Medicine · 23d
Cleared Nov 30, 1979
TAYLOR TRACTION CORD
K792248 · HST
Taylor Medical Equipment
Neurology · 23d
Cleared Nov 30, 1979
TEMPO
K792274 · EJS
Deringer-Ney, Inc.
Dental · 17d
Cleared Nov 30, 1979
DAHLBERG MODEL AE HIGH FREQUENCY / AID
K792278 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 30, 1979
CASTROVIEJO VASCULAR NEEDLEHOLDER 538425
K792309 · GEN
Edward Weck, Inc.
General & Plastic Surgery · 14d
Cleared Nov 29, 1979
CARDIAC PACEMAKER P4000 SER. & P1000
K791920 · DXY
Vitatron Medical BV
Cardiovascular · 65d
Cleared Nov 29, 1979
MODEL IV 6500 FORMULATOR
K792142 · FRN
Valleylab, Inc.
General Hospital · 34d
Cleared Nov 29, 1979
ARCOLITH 2100-CARDIAC PULSE GENERATOR
K792216 · DXY
Arco Medical Products Co.
Cardiovascular · 24d
Cleared Nov 29, 1979
ARCOLITH 3020-CARDIAC PULSE GENERATOR
K792299 · DXY
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Nov 27, 1979
ANTI-HUMAN IGG SERUM
K791281 · DEW
Diagnostica, Inc.
Immunology · 140d
Cleared Nov 27, 1979
ANTI-HUMAN LAMBDA SERUM
K791283 · DEH
Diagnostica, Inc.
Immunology · 140d
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